Medical instrument product compliance assisting method and device and electronic equipment

Abstract

The invention relates to the technical field of computers and internet platforms, in particular to a medical instrument product compliance assisting method and device and electronic equipment. Comprising the steps that a product compliance whole process stage selection interface is displayed, the interface comprises a plurality of control sets corresponding to a plurality of stages in a product compliance whole process, and each control set is provided with a regulation summary control and other related information controls; displaying a regulation interface of a corresponding stage after responding to a user selection operation, wherein the interface provides a regulation list, an accurate query page and / or a practical classification selection page; the accurate query page is provided with multi-dimensional classification options; the practical classification selection page provides common item options according to stages; and finally, displaying the matched law and regulation list according to the query condition selected by the user. Therefore, the whole compliance process is innovatively divided into a plurality of stages, laws and regulations query and practical tools are integrated in each stage, multi-dimensional combination retrieval and quick positioning of common items are supported, the compliance working efficiency is remarkably improved, and the compliance risk is reduced.

Description

Technical Field

[0001] The present disclosure relates to the field of computer and Internet platform technology, and in particular to a medical device product compliance assistance method, apparatus, and electronic equipment. Background Art

[0002] The medical device industry is a highly regulated sector worldwide, and its products are directly related to patients' lives, health, and medical safety. Therefore, strict compliance with regulatory requirements is not only a fundamental responsibility of medical device companies but also an insurmountable bottom line for all industry practitioners.

[0003] With the rapid development of the medical device industry, the global regulatory environment is becoming increasingly stringent. Regulatory agencies are continuously improving the medical device regulatory system, placing higher demands on medical device compliance. Medical device companies must adhere to strict, end-to-end regulatory requirements, encompassing the "Medical Device Supervision and Administration Regulations" and supporting regulations, normative documents, technical guidelines, and other multi-layered regulatory documents. However, existing approaches to medical device compliance suffer from numerous shortcomings, making it difficult for companies to efficiently and accurately meet regulatory requirements. Compliance omissions may even expose them to legal risks.

[0004] First, regulatory retrieval is inefficient, making accurate matching difficult. Medical device regulations are multifaceted and frequently updated. Companies often rely on manual searches and paper documents, lacking effective tools to track these changes. This makes it difficult to quickly identify regulatory requirements applicable to specific scenarios, and information lags can easily lead to compliance risks. For example, when conducting clinical trials, companies must simultaneously reference the Good Clinical Practice Guidelines for Medical Devices, relevant technical guidelines, and exemption catalogs. However, existing systems lack intelligent screening capabilities, making compliance work time-consuming and labor-intensive, and prone to missing key requirements.

[0005] Secondly, compliance elements are fragmented and lack systematic integration. Medical device development, from R&D to delisting, involves multiple stages, each with specific compliance requirements. Existing technologies lack a platform that organically integrates requirements across these stages, making it difficult for companies to fully grasp the key compliance points for their products at every stage, leading to fragmented management. For example, a company may strictly control production quality but neglect cold chain management requirements in the operational phase, compromising overall compliance.

[0006] Furthermore, regulatory updates are lagging behind, hindering timely responses from businesses. Regulations, standards, and guidelines issued by regulatory authorities are subject to dynamic adjustments. For example, the 2021 revision of the Medical Device Supervision and Administration Regulations significantly increased penalties for violations and added a new "personnel-specific penalties" clause. However, businesses often struggle to stay abreast of the latest regulatory changes, often clinging to obsolete or outdated regulations, leading to accumulating compliance risks. For example, some businesses, failing to promptly adjust their quality management systems, were found to be non-compliant with the latest requirements during unannounced inspections, resulting in penalties such as production suspension and rectification.

[0007] How to avoid the above problems existing in the compliance work of existing technologies, help medical device companies improve the standardization, accuracy and timeliness of compliance work, reduce compliance risks, and accelerate the product launch process is an issue that needs to be solved urgently. Summary of the Invention

[0008] In order to solve the problems in the related art, the embodiments of the present disclosure provide a medical device product compliance assistance method, apparatus and electronic equipment.

[0009] In a first aspect, an embodiment of the present disclosure provides a method for assisting medical device product compliance, the method comprising:

[0010] Displaying a product compliance full process stage selection interface, the product compliance full process stage selection interface includes multiple control groups, each of which corresponds to a multiple stage in the product compliance full process, and the control group includes a regulatory summary control and other related information controls for the corresponding stage;

[0011] In response to a user's selection of any regulatory summary control, a regulatory interface for the corresponding stage is displayed. The regulatory interface includes a list of regulations for the corresponding stage, a precise query page, and / or a practical classification selection page. The precise query page includes multiple option sets, each option set including multiple different category options in a corresponding regulatory classification method. The regulatory classification methods include: legal effect level, product classification, product supervision category, and legislative stage. The practical classification selection page includes multiple option groups, each of which corresponds to multiple stages in the full product compliance process, and includes options for commonly used items in the corresponding stage.

[0012] In response to the user's selection of any one or more category options in the precise query page, or the selection of any common matters option in the practical classification selection page, a corresponding list of regulations is displayed; wherein, the corresponding list of regulations is retrieved using keywords determined based on the user's selection of any one or more category options in the precise query page, or the selection of any common matters option in the practical classification selection page.

[0013] According to an embodiment of the present disclosure, the multiple control groups include: innovation and development control group, product inspection control group, clinical evaluation control group, registration and filing control group, production control group, operation control group, usage control group, and supervision and inspection control group.

[0014] According to an embodiment of the present disclosure, other related information controls of the innovation and development control group include: an innovation product catalog control, which is used to provide a catalog of innovation public products and a catalog of approved innovation products; a priority product catalog control, which is used to provide a catalog of priority products; an innovation and priority product review report summary control, which is used to provide an innovation and priority product review report;

[0015] Other related information controls of the product inspection control group include: inspection display control, which is used to display relevant information of the standard technical committee; industry standard full text disclosure system control, which is used to index the currently valid mandatory industry standards, recommended industry standards and download the collected guiding technical documents;

[0016] Other related information controls of the clinical evaluation control group include: clinical trial information query control, which is used to provide a clinical trial information query page and a clinical trial information display page; clinical-free IVD reagent product catalog control, which is used to provide a clinical-free IVD reagent product catalog;

[0017] Other related information controls of the registration and filing control group include: a review report information summary control, which is used to provide a summary of the review report information; a registration technical review guideline summary control, which is used to provide a summary of the registration technical review guideline;

[0018] Other related information controls of the production control group include: a daily record of prohibited commissioned production control, which is used to provide a daily record of prohibited commissioned production; a production key supervision catalog control, which is used to provide a production key supervision catalog;

[0019] Other related information controls of the business control group include: a key business supervision catalog control, which is used to provide a key business supervision catalog; a recalled product list control, which is used to provide a recalled product list;

[0020] Other related information controls of the control group include: a quality supervision announcement control, which is used to publish official quality announcements; and an adverse event information control, which is used to provide adverse event information.

[0021] According to an embodiment of the present disclosure, the method further includes:

[0022] Displaying an administrative approval item selection interface, the administrative approval item selection interface including multiple item groups, each of which corresponds to a plurality of stages in the product compliance process, and the item group includes administrative approval item options in the corresponding stage;

[0023] In response to the user's selection of any administrative approval matter option in the administrative approval matter selection interface, the corresponding administrative approval matter description page is displayed, and the administrative approval matter description page includes: an application basis page, an application materials page, a process and time limit page, an approval result page and an attachment download page; the application basis page includes a corresponding list of regulations; wherein, the corresponding list of regulations included in the application basis page is obtained by keyword retrieval based on the user's selection of any administrative approval matter option in the administrative approval matter selection interface.

[0024] According to an embodiment of the present disclosure, for the category options in each regulation classification method, the category options corresponding to the legal effectiveness level include: laws, administrative regulations, departmental regulations, normative documents, announcements and notices, working documents, technical guidelines and review points; the category options corresponding to the product classification include: domestic Class I, domestic Class II, domestic Class III, overseas Class I, overseas Class II and overseas Class III; the category options corresponding to the product supervision category include: medical devices, in vitro diagnostic reagents, in vitro diagnostic reagents subject to drug management, drug-device combination products and inactive medical devices; the category options corresponding to the legislative stage include: formal draft, draft for solicitation and abolished.

[0025] According to an embodiment of the present disclosure, the regulatory interface further includes a keyword query control group, the keyword query control group including a keyword query range selection control and a keyword input control, the keyword query range selection control is used to provide a selectable keyword query range, and the keyword input control is used to receive a keyword input by a user;

[0026] In response to the user's selection of the keyword query control group and the keyword input, a corresponding list of regulations is displayed.

[0027] According to an embodiment of the present disclosure, the list items in the regulations list are used to display basic attribute information of the corresponding regulations; wherein the basic attribute information includes: regulation title, original document number, issuing agency, issuing date and effective date.

[0028] According to an embodiment of the present disclosure, the list items in the regulations list are also used to display the corresponding stages and content summary information of the corresponding regulations; wherein the corresponding stages include at least one of the following stages: innovation and research and development, product inspection, clinical evaluation, registration and filing, production, operation, use, supervision and inspection, and the content summary information includes: purpose and significance information, scope of application information, regulatory agency information, regulatory object information, regulatory description information, how to implement information and when to take effect information.

[0029] In a second aspect, an embodiment of the present disclosure provides a medical device product compliance assistance device, the device comprising:

[0030] The product compliance full-process stage selection module is configured to: display a product compliance full-process stage selection interface, wherein the product compliance full-process stage selection interface includes multiple control groups, each of which corresponds to a plurality of stages in the product compliance full-process, and each control group includes a regulatory summary control and other relevant information controls for the corresponding stage;

[0031] A regulatory interface display module is configured to: in response to a user selecting any regulatory summary control, display a regulatory interface for the corresponding stage, the regulatory interface including a list of regulations for the corresponding stage, a precise query page, and / or a practical classification selection page, the precise query page including multiple option sets, each option set including multiple different category options from a corresponding regulatory classification method, the regulatory classification methods including: legal effect level, product classification, product supervision category, and legislative stage, the practical classification selection page including multiple option groups, each of which corresponds to multiple stages in the full product compliance process, and each option group includes options for commonly used items in the corresponding stage;

[0032] The regulations list generation module is configured to: display a corresponding regulations list in response to a user's selection of any one or more category options in the precise query page, or a selection of any commonly used items option in the practical classification selection page; wherein the corresponding regulations list is retrieved using keywords determined based on the user's selection of any one or more category options in the precise query page, or a selection of any commonly used items option in the practical classification selection page.

[0033] According to an embodiment of the present disclosure, the device further comprises: an administrative approval matter processing module; the administrative approval matter processing module comprises: an administrative approval matter selection module and an administrative approval matter description module; wherein:

[0034] The administrative approval item selection module is configured to: display an administrative approval item selection interface, wherein the administrative approval item selection interface includes multiple item groups, each of which corresponds to a plurality of stages in the product compliance process, and each item group includes administrative approval item options in the corresponding stage;

[0035] The administrative approval matter description module is configured to: in response to the user's selection of any administrative approval matter option in the administrative approval matter selection interface, display the corresponding administrative approval matter description page, the administrative approval matter description page including: application basis page, application materials page, process and time limit page, approval result page and attachment download page; the application basis page includes a corresponding list of regulations; wherein, the corresponding list of regulations included in the application basis page is retrieved using keywords determined based on the user's selection of any administrative approval matter option in the administrative approval matter selection interface.

[0036] In a third aspect, an embodiment of the present disclosure provides an electronic device, comprising the apparatus described in any one of the second aspects; or, comprising a memory and a processor; wherein the memory is used to store one or more computer instructions, wherein the one or more computer instructions are executed by the processor to implement the method described in any one of the first aspects.

[0037] In a fourth aspect, an embodiment of the present disclosure provides a computer-readable storage medium having computer instructions stored thereon, which implement the method described in any one of the first aspects when executed by a processor.

[0038] In a fifth aspect, an embodiment of the present disclosure provides a computer program product, comprising a computer program, which implements any one of the methods in the first aspect when executed by a processor.

[0039] According to the technical solution provided by the embodiments of the present disclosure, the entire process of medical devices from research and development to delisting is innovatively divided into multiple key stages. The traditional fragmented compliance management model is reconstructed from the perspective of "full product compliance process", and functional modules such as regulatory query and common matters guidance are integrated into each stage to form a structured compliance management framework.

[0040] Specifically, on the one hand, through phased architecture design and vertical stage integration, the entire medical device product compliance process is divided into eight key stages: innovation and development, product testing, clinical evaluation, registration and filing, production, operation, use, supervision and inspection. A regulatory database and functional modules that closely match each stage are established, thus breaking through the traditional model of classifying by regulatory type and organizing compliance resources according to the actual product development process. For example, in the "clinical evaluation" stage, all relevant resources such as clinical trial specifications and clinical exemption catalogs are centrally provided to avoid users searching across systems.

[0041] On the other hand, through the multi-dimensional intelligent retrieval system and horizontal functional integration, a multi-dimensional classification system including legal effectiveness levels, product classifications, regulatory categories, legislative stages, etc. is constructed, supporting precise query and practical classification dual-path retrieval, significantly improving the efficiency of regulatory positioning. In addition, through the dynamic association mechanism, a three-dimensional association of stage-regulations-common matters is achieved. After the user selects a specific stage, the system automatically associates and displays relevant regulations and common matters, forming a closed-loop management that facilitates the user's subsequent analysis and decision-making. In this way, through multi-dimensional cross-screening, accurate positioning from the macro level (such as administrative regulations) to the micro level (such as the technical review points of a certain type of product) is achieved.

[0042] Therefore, the technical solution provided by the embodiments of the present disclosure avoids the problems existing in traditional compliance work, helps medical device companies significantly improve the standardization, accuracy and timeliness of compliance work, reduces compliance risks, and accelerates the product launch process.

[0043] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Other features, objectives and advantages of the present disclosure will become more apparent through the following detailed description of non-limiting embodiments in conjunction with the accompanying drawings. In the accompanying drawings:

[0045] Figure 1 A flow chart of a medical device product compliance assistance method according to an embodiment of the present disclosure is shown;

[0046] Figure 2 A schematic diagram illustrating a specific implementation of a product compliance full-process stage selection interface according to an embodiment of the present disclosure is shown;

[0047] Figure 3 A schematic diagram illustrating a specific implementation of a regulations interface according to an embodiment of the present disclosure is shown;

[0048] Figure 4 A schematic diagram showing a specific implementation of a practical category selection page according to an embodiment of the present disclosure is shown;

[0049] Figure 5 A flowchart of another medical device product compliance assistance method according to an embodiment of the present disclosure is shown;

[0050] Figure 6 A schematic diagram illustrating a specific implementation of an administrative approval item selection page according to an embodiment of the present disclosure is shown;

[0051] Figure 7 A schematic diagram illustrating a specific implementation of an administrative approval matter description page according to an embodiment of the present disclosure is shown;

[0052] Figure 8 A structural block diagram of a medical device product compliance assistance device according to an embodiment of the present disclosure is shown;

[0053] Figure 9 A structural block diagram of an electronic device according to an embodiment of the present disclosure is shown. DETAILED DESCRIPTION

[0054] Hereinafter, exemplary embodiments of the present disclosure will be described in detail with reference to the accompanying drawings so that those skilled in the art can easily implement them. In addition, for the sake of clarity, parts not related to the description of the exemplary embodiments are omitted in the accompanying drawings.

[0055] In the present disclosure, it should be understood that terms such as "include" or "have" are intended to indicate the presence of features, numbers, steps, actions, components, parts, or combinations thereof disclosed in the present specification, and are not intended to exclude the possibility that one or more other features, numbers, steps, actions, components, parts, or combinations thereof exist or are added.

[0056] It should also be noted that, in the absence of conflict, the embodiments and features of the embodiments of the present disclosure may be combined with each other. The present disclosure will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0057] As mentioned above, there are three core problems with existing medical device compliance work: First, regulatory search efficiency is low. Due to the complex and frequently updated medical device regulatory system, companies relying on manual searches find it difficult to accurately locate applicable clauses, resulting in the omission of important regulatory requirements. Second, compliance management is fragmented. Compliance requirements at all stages of the product compliance process are managed separately and lack system integration. This makes it difficult for companies to form a complete compliance view, which easily leads to management blind spots. Third, regulatory update response lags, making it difficult for companies to track dynamically changing regulatory requirements in a timely manner. For example, after the implementation of the newly revised regulations in 2021, some companies still use the old regulations, facing risks such as unqualified unannounced inspections and production suspensions for rectification. These problems have led to high compliance costs for companies, making it difficult to meet increasingly stringent regulatory requirements. There is an urgent need for intelligent solutions to achieve accurate regulation matching, full-process integration, and dynamic updates.

[0058] To address these issues in existing technologies, this disclosure provides a comprehensive medical device product compliance support solution based on the entire product compliance process. By building a digital compliance platform for the entire process, it achieves three major breakthroughs: from passive response to active prevention, from fragmented management to system integration, and from manual search to intelligent push notifications. This solution offers significant technological innovation and industrial application value.

[0059] Figure 1A flowchart of a medical device product compliance assistance method according to an embodiment of the present disclosure is shown. In one specific application scenario, the method is applied to a client, which is in communication with a backend server. In another specific application scenario, the method is applied to a designated device. The backend server or the designated device stores a regulatory database containing multiple regulations related to medical device products.

[0060] like Figure 1 As shown, the method includes the following steps S110 to S130:

[0061] In step S110, a product compliance full process stage selection interface is displayed, and the product compliance full process stage selection interface includes multiple control groups, which respectively correspond to multiple stages in the product compliance full process, and the control groups include regulatory summary controls and other related information controls for the corresponding stages.

[0062] Among them, medical device products include but are not limited to common medical devices such as treatment, monitoring, and rehabilitation equipment (such as surgical instruments and pacemakers), as well as in vitro diagnostic reagents (IVD) for in vitro detection of samples (such as blood glucose test strips and PCR reagents). In the present disclosure, the inventors of the present disclosure, based on the study of the entire process of medical device products from concept design to market exit, combined with current domestic and foreign regulatory requirements and industry practices, divide the entire product compliance process into the following 8 stages in accordance with the order of product development and compliance review processes: innovation and research and development, product testing, clinical evaluation, registration and filing, production, operation, use, supervision and inspection. This division method takes the current regulatory framework as the core basis, focuses on the key compliance actions of each link, and ensures that the stage division is highly consistent with actual product development and regulatory requirements.

[0063] Specifically, the eight stages described above fully cover the entire product development process, from concept design (innovation and development) to market exit (supervision and inspection). Each stage corresponds to a clear compliance review focus (e.g., clinical evaluation corresponds to safety verification, and registration and filing corresponds to market access), avoiding aspects that may be overlooked in traditional categorization (e.g., compliance in the operational phase is often lumped into the production or use phase, "product inspection" and "clinical evaluation" are combined into "testing," or the "operation" phase is ignored). Separating high-risk stages (e.g., clinical evaluation and production) reflects a focus on key risk areas and aligns with the regulatory authorities' tiered review logic for product safety and efficacy. By further refining the stages (e.g., separating "registration and filing" from "production"), regulatory requirements for each stage are independently reviewed, thereby reducing cross-risk. Furthermore, the sequence of stages strictly follows the natural flow of product development (e.g., completion of inspection and clinical evaluation is required before registration), avoiding compliance risks caused by process inversion. Finally, each stage is assigned to a different responsible party (e.g., the development phase belongs to the company's R&D department, the supervision phase belongs to the regulatory agency), which helps clarify the boundaries of compliance responsibilities.

[0064] It should be noted that the above-mentioned division of the entire product compliance process is only a specific division method that adapts to the current product compliance process. Due to the dynamic evolution of medical device regulatory policies, if the compliance process is adjusted in the future due to regulatory updates, technological development or changes in industry needs, the number, name or content of the stages of this division method will be optimized accordingly to ensure that it is always consistent with the latest compliance requirements.

[0065] According to an embodiment of the present disclosure, corresponding to the various stages in the above product compliance process, the multiple control groups include: innovation and development control group, product inspection control group, clinical evaluation control group, registration and filing control group, production control group, operation control group, use control group, and supervision and inspection control group.

[0066] Figure 2 Schematic diagram of the specific implementation of the product compliance full process stage selection interface according to the embodiment of the present disclosure is shown. Figure 2 As shown, where:

[0067] For the innovation and development control group, the corresponding regulatory summary control is the innovation and development regulatory summary. Other relevant information controls of the innovation and development control group include but are not limited to: an innovation product catalog control, which is used to provide a catalog of innovative public products and a catalog of approved innovative products; a priority product catalog control, which is used to provide a catalog of priority products; and an innovation and priority product review report summary control, which is used to provide a review report on innovation and priority products.

[0068] For the product inspection control group, the corresponding regulation summary control is the product inspection regulation summary. Other relevant information controls of the product inspection control group include but are not limited to: an inspection display control, which is used to display relevant information of the standard technical committee; an industry standard full-text disclosure system control, which is used to index currently valid mandatory industry standards, recommended industry standards and download included guiding technical documents.

[0069] For the clinical evaluation control group, the corresponding regulatory summary control is the clinical evaluation regulatory summary. Other relevant information controls of the clinical evaluation control group include but are not limited to: a clinical trial information query control, which is used to provide a clinical trial information query page and a clinical trial information display page; and a clinical-free IVD reagent product catalog control, which is used to provide a clinical-free IVD reagent product catalog.

[0070] For the registration and filing control group, the corresponding regulation summary control is the registration and filing regulation summary. Other relevant information controls of the registration and filing control group include but are not limited to: a review report information summary control, which is used to provide a summary of review report information; and a registration technical review guidelines summary control, which is used to provide a summary of registration technical review guidelines.

[0071] For the production control group, the corresponding regulation summary control is the production regulation summary. Other relevant information controls of the production control group include but are not limited to: a daily record of prohibited commissioned production control, which is used to provide a daily record of prohibited commissioned production; and a production key supervision catalog control, which is used to provide a production key supervision catalog.

[0072] For the business control group, the corresponding regulation summary control is a summary of business regulations. Other relevant information controls of the business control group include but are not limited to: a key business supervision catalog control, which is used to provide a key business supervision catalog; and a recalled product list control, which is used to provide a recalled product list.

[0073] For the usage control group, the corresponding regulation summary control is the usage regulation summary. Other related information controls of the usage control group include but are not limited to: a quality supervision announcement control, which is used to publish official quality announcements; and an adverse event information control, which is used to provide adverse event information.

[0074] For the Supervision and Inspection control group, the corresponding Regulation Summary control is Supervision and Inspection Regulation Summary.

[0075] When operating, the user can click the corresponding control in one of the stages to choose to view the interface content corresponding to the selected control in that stage.

[0076] In practice, each stage in the product compliance process can be numbered, and regulations and other related information can be categorized using the stage number. This way, when a user selects to view the regulatory summary for a stage in the product compliance process stage selection interface, only the regulations corresponding to that stage are displayed. Table 1 shows the correspondence between the product compliance process stages and stage numbers.

[0077] Table 1 Correspondence between product compliance process stages and stage numbers

[0078]

[0079]

[0080] In this disclosure, regulatory summaries and other relevant information are bound to stages to facilitate users to quickly locate required information and avoid information overload.

[0081] In step S120, in response to the user's selection operation on any regulation summary control, the regulation interface of the corresponding stage is displayed, and the regulation interface includes the regulation list of the corresponding stage, and also includes a precise query page and / or a practical classification selection page. The precise query page includes multiple option sets, and each option set includes multiple different category options in a corresponding regulation classification method. The regulation classification method includes: legal effect level, product classification, product supervision category, and legislative stage.

[0082] Specifically, for the category options in each regulatory classification method, the category options corresponding to the legal effectiveness level include but are not limited to: laws, administrative regulations, departmental regulations, normative documents, announcements, working documents, technical guidelines and review points; the category options corresponding to the product classification include but are not limited to: domestic Class I, domestic Class II, domestic Class III, overseas Class I, overseas Class II and overseas Class III; the category options corresponding to the product supervision category include but are not limited to: medical devices (especially non-in vitro diagnostic reagents), in vitro diagnostic reagents, in vitro diagnostic reagents under drug management, drug-device combination products and inactive medical devices; the category options corresponding to the legislative stage include but are not limited to: formal draft, draft for solicitation and repealed.

[0083] In the legal system, regulations at different levels have different legal effects, scopes of application, and drafting bodies. For the medical device regulatory field, these documents constitute a complete regulatory system. In this publication, a multi-dimensional, labeled database design is employed. By crawling regulatory data from relevant department websites, regular expressions are used to extract key information from document numbers. A rule engine and machine learning classification are then used to perform multi-level classification and labeling, thereby establishing an associated index.

[0084] Specifically, when creating regulatory data in the regulatory database, the backend server or designated device first obtains regulatory documents related to medical devices from a pre-set third-party platform (e.g., a relevant department website), and then extracts and analyzes the obtained regulatory documents. For example, the server extracts basic attribute information (e.g., regulatory title, original document number, issuing agency, issuance date, and effective date) from the regulatory documents, generates content summaries based on the regulatory documents, and categorizes and labels the regulations based on their content.

[0085] Specifically, for classifications related to the stages of the product compliance process, the obtained regulations are categorized and labeled according to the stages of the product compliance process, generating corresponding classification and labeling information. For example, regulations related to the innovation and development stages are labeled as corresponding to the "Innovation and Development" stage. For classifications related to precise queries, regulations are categorized and labeled according to the legal effect level (e.g., laws, administrative regulations, departmental regulations, etc.), product classification (e.g., Domestic Class I, Domestic Class II, etc.), product regulatory category (e.g., medical devices, in vitro diagnostic reagents, etc.), and legislative stage (e.g., draft, official draft, etc.). For example, the Medical Device Standards Management Measures are labeled as the "Innovation and Development" stage of the product compliance process, the legal effect level is "departmental regulations," the product classification is "medical devices," the product regulatory category is "Domestic Class I," and the legislative stage is "official draft." For practical classifications, regulations are labeled according to the various stages of the product compliance process (e.g., registration stage, production stage, operation stage, etc.) and the common issues in each stage. For example, regulations related to the division of registration units are labeled as "Registration stage - Registration unit division."

[0086] After completing the information extraction and analysis of the acquired regulations, the corresponding information of each regulation (including basic attribute information, content summary information and classification labeling information) is stored in the regulations database, and the corresponding data table structure is established, such as the regulations information table, classification labeling table, etc., to facilitate subsequent efficient queries.

[0087] According to an embodiment of the present disclosure, the list of regulations for the corresponding stage includes regulations corresponding to the specified stage in the product compliance process selected by the user, that is, the list of regulations for the corresponding stage is retrieved using a keyword determined based on the user's selection of the specified stage in the product compliance process. For example, if the user selects the regulation summary control corresponding to the "Innovation and Development" stage (i.e., Innovation and Development Regulation Summary), the system converts the selection into a corresponding keyword (e.g., Innovation and Development), then constructs a database query statement based on the keyword, sends the constructed query statement to the regulation database, executes the query operation, and retrieves the regulation records that meet the keyword conditions from the regulation information table. Next, the regulations retrieved from the regulation database are sorted, and key information such as the regulation name, regulation number, issuing agency, and issuance date are extracted and organized according to a certain format. Finally, the sorted regulation list is displayed on the interface, and the user can see all the regulatory information that meets their selection criteria on the interface, so as to further view the detailed content of the regulation or perform other operations.

[0088] In this disclosure, through the above-mentioned regulatory classification implementation method, the system can compress the traditional regulatory research work that requires several days of manual time to minutes, while ensuring regulatory coverage and real-time updates, significantly reducing corporate compliance risks.

[0089] In addition, given that in actual compliance operations, companies must first comply with the "Medical Device Supervision and Administration Regulations" (administrative regulations), then apply in accordance with the "Registration Management Measures" (departmental regulations), and finally refer to the guidelines to complete the information, and considering that technical guidelines and review points directly affect the direction of research and development (such as clinical trial design), therefore, in this disclosure, by conducting the above multi-dimensional classification of regulations, users can accurately match document levels and requirements, significantly improving compliance efficiency. For example: R&D personnel can quickly locate product technical requirements through "technical guidelines + review points", registration specialists can prepare registration materials according to the "laws → regulations → normative documents" level, thereby avoiding omissions, and quality managers can pay attention to "announcements" to respond to regulatory dynamics (such as recall requirements).

[0090] Figure 3 Schematic diagram of the specific implementation of the regulations interface according to the embodiment of the present disclosure is shown. In order to clearly define the number of each type of regulations, such as Figure 3 As shown, the number of regulations corresponding to each category of regulations can be displayed after each category option. Take the operation of clicking the innovation and development regulations summary control in the product compliance full process selection interface as an example, the relevant regulations involved in the innovation and development stage are listed on the "Current Regulations Library" page ( Figure 3 Only some of the regulations are listed for example), and users can view the details of any regulation listed in the regulations list.

[0091] In this disclosure, the regulations interface also includes a regulatory update reminder function to promptly notify users of the latest regulatory developments. In implementing this function, an "Update Reminder" label can be added to the regulations interface, marking recently updated regulations. The latest versions of regulations are then regularly obtained from official channels and compared with locally stored regulations to detect any updates. When regulatory updates are detected, users are notified via push notifications, emails, or in-site messages. Additionally, a regulatory update log can be provided, allowing users to view the update history and specific content of regulations.

[0092] This disclosure provides the following beneficial technical effects by providing a regulatory update reminder function:

[0093] 1. Ensure compliance. Medical device industry regulations are frequently updated. Failure to stay abreast of new regulations can result in product production, sales, and other processes failing to meet the latest requirements, exposing users to legal risks. The regulatory update reminder feature allows users to be immediately informed of regulatory changes, allowing them to adjust their operations promptly and ensure compliance at all times. For example, when new medical device registration regulations are introduced, companies can quickly prepare registration materials in accordance with the new requirements, avoiding registration delays or failures due to unfamiliarity with the regulations.

[0094] 2. Save time and energy. Users no longer need to frequently check official channels for regulatory updates, saving significant time and effort. The system automatically detects and alerts users, allowing them to devote more resources to their core business. For example, medical device R&D personnel no longer need to monitor regulatory development, allowing them to focus on product development and improving R&D efficiency.

[0095] 3. Provide a basis for decision-making. Regulatory updates are often accompanied by adjustments to industry policies and changes in the market environment. Staying up-to-date on regulatory updates helps users plan their business development and make more informed decisions. For example, when regulations raise production standards for a certain type of medical device, companies can assess their production capabilities in advance and decide whether to upgrade technology or adjust their product mix.

[0096] 4. Enhance user experience. Multiple reminder methods, such as push notifications, emails, or in-site messages, cater to different users' habits and needs, allowing users to obtain regulatory updates in the most convenient way, thereby increasing user satisfaction and loyalty to the product.

[0097] In addition, the regulations interface includes a multi-dimensional regulations comparison function, allowing users to compare the content of multiple regulations simultaneously. This function can be implemented by adding a "Compare" button to the regulations interface, allowing users to select multiple regulations for comparison. After the user selects multiple regulations, the regulations comparison interface is displayed, displaying the selected regulations side by side. The comparison interface can highlight the differences between the regulations, making it easier for users to quickly identify them.

[0098] This disclosure provides a multi-dimensional regulatory comparison function, which has the following beneficial technical effects:

[0099] 1. Improve comprehension efficiency. Medical device regulations are complex, and different regulations may overlap and intersect. The multi-dimensional regulatory comparison function displays multiple regulations side by side and highlights differences, allowing users to intuitively compare the provisions of different regulations, quickly understand the similarities and differences between regulations, and deepen their understanding of the regulations. For example, when comparing regulations related to medical device production and operation, users can clearly see the different requirements in terms of production licensing, quality control, and other aspects.

[0100] 2. Assisting with regulatory application. In actual business operations, users may need to select applicable regulations based on different circumstances. The multi-dimensional regulatory comparison function can help users accurately determine the scope and conditions of application of different regulations, avoiding compliance issues caused by incorrect application of regulations. For example, when conducting cross-border medical device business, companies can compare relevant domestic and international regulations to determine applicable regulatory standards and ensure legal and compliant operations.

[0101] 3. Support for learning and research. For researchers, students, and other users in the medical device industry, the multi-dimensional regulatory comparison feature provides a convenient learning and research tool. By comparing regulations from different periods and regions, they can analyze regulatory evolution trends and industry policy orientations, providing strong support for academic research and industry analysis.

[0102] 4. Improve work efficiency. When handling complex compliance matters, users no longer need to switch back and forth between multiple regulatory documents to search for information. The multi-dimensional regulatory comparison function allows users to obtain the required information all at once, greatly improving work efficiency. For example, when providing compliance consulting services to clients, legal advisors can quickly compare relevant regulations and provide clients with accurate and comprehensive advice.

[0103] According to an embodiment of the present disclosure, the practical classification selection page includes multiple option groups, which respectively correspond to multiple stages in the entire product compliance process, and the option groups include options for commonly used matters in the corresponding stages.

[0104] In this disclosure, "practical classification" is a compilation and summary of commonly used items in my country's medical device regulations. Each practical classification has one or more corresponding stages. Table 2 shows the common items involved in each stage of the entire product compliance process and their corresponding relationship with the stage number. When specifically associating regulations with specific practical classification items, only the corresponding common items under the selected stage can be selected, and the multiple selection principle is adopted. For example: the stages corresponding to national and industry standards are "innovation and research and development", "product inspection", and "registration and filing". The practical classification can correspond to "instructions", "label identification", "product technical requirements", "registration inspection", and "technical review", but "clinical evaluation" cannot be selected. In addition, it should be noted that the specific practical classification shown in Table 2 is only a specific classification method that adapts to the current product compliance process. The corresponding relationship described in Table 2 may change with the update of regulations and needs to be updated in a timely manner.

[0105] Table 2 Correspondence between common items in practical classification and stage numbers

[0106]

[0107]

[0108] Figure 4 Schematic diagram of a practical classification selection page according to an embodiment of the present disclosure is shown. Figure 4 As shown, in each stage, the practical classification and common matters involved in the corresponding stage are clearly listed, so that users can click to view the regulations related to a specific common matter in the corresponding stage. Figure 4 The "Innovation & Development" shown in the figure corresponds to the "Innovation and Development" stage in the entire product compliance process, the "Registration & Filing" corresponds to the "Registration and Filing" stage in the entire product compliance process, and the "Supervision & Inspection" corresponds to the "Supervision and Inspection" stage in the entire product compliance process.

[0109] In this disclosure, the beneficial technical effects of the corresponding stage regulations are further found by using practical classification, which is reflected in:

[0110] 1. Significantly improve the efficiency of regulatory queries. This is specifically reflected in scenario-based direct access. By presetting high-frequency requirements as commonly used options, users can directly access the target regulations with just one click without having to filter layer by layer, saving a lot of time compared to traditional search methods. In addition, it prevents users from getting lost in multi-level classifications, and is particularly suitable for non-legal professionals (such as R&D engineers and quality specialists), reducing operational complexity. For example: Select "Clinical Evaluation → Clinical Trial Approval" to jump directly to the "Guidelines for Medical Device Clinical Trial Approval" and related GCP specifications.

[0111] 2. Accurately match actual workflows. By strongly linking stages and tasks, the option groups for each stage are designed based on real business scenarios, allowing users to select options based on their actual work needs rather than passively adapting to regulatory classification logic. Furthermore, it dynamically adapts to industry changes and can update options based on regulatory hotspots, making it more flexible than fixed classifications.

[0112] 3. Reduced compliance risk. Experts pre-set common options to ensure that users will not overlook key regulations (such as the mandatory "Clinical Evaluation Report Requirements" in the "Registration Phase"). If users search on their own, they may miss non-mandatory but critical documents such as the "Technical Guidelines for Clinical Evaluation of Medical Devices."

[0113] This paper uses practical classification design to achieve scenario-based guidance. Through scenario-based navigation and business language mapping, it solves the core pain points of "incomplete search, inaccurate search, and low efficiency" in medical device compliance retrieval, thereby improving user experience and compliance efficiency.

[0114] In step S130, in response to the user's selection of any one or more category options in the precise query page, or the selection of any common matters option in the practical classification selection page, a corresponding list of regulations is displayed; wherein, the corresponding list of regulations is retrieved using keywords determined based on the user's selection of any one or more category options in the precise query page, or the selection of any common matters option in the practical classification selection page.

[0115] Similar to the previously mentioned display of the regulatory list for the corresponding stage, when a user selects any one or more category options on the precise query page, the system records the user's selection. For example, a user selects the three category options of "Departmental Regulations" for legal effectiveness, "Domestic Class I" for product classification, and "Medical Devices" for product regulatory category. The system converts these selections into corresponding keyword combinations. For these selections, a keyword combination such as "Departmental Regulations AND Domestic Class I AND Medical Devices" can be generated. When a user selects any of the commonly used options on the practical category selection page, the system also records the user's selection. For example, a user selects the commonly used option "Innovation and Research and Development - Classification Definition." The system converts this selection into a corresponding keyword combination. For these selections, a keyword combination such as "Innovation and Research and Development AND Classification Definition" can be generated. Then, a database query statement is constructed based on the keyword combination or keywords generated by the user's selection, and the constructed query statement is sent to the regulatory database to execute the query operation, and the regulatory records that meet the keyword conditions are retrieved from the regulatory information table. Next, the regulations retrieved from the regulatory database are sorted out, and key information such as the regulatory name, regulatory number, issuing agency, and issuing date are extracted and organized according to a certain format. Finally, the sorted regulatory list is displayed on the interface, and users can see all regulatory information that meets their selection conditions on the interface, so that they can further view the detailed content of the regulations or perform other operations.

[0116] In the present disclosure, based on the user's selection of any one or more category options on the precise query page, or the selection of any common item option on the practical classification selection page, a keyword search is performed to obtain a corresponding list of regulations, which has the following beneficial technical effects:

[0117] 1. Improved search efficiency. This is mainly reflected in two aspects. On the one hand, it accurately locates the scope of regulations. Specifically, on the precise query page, users can select one or more category options according to the classification method of regulations (such as legal effect level, product classification, etc.). For example, if the user is only interested in administrative regulations in the field of medical devices, by selecting the two category options of "Legal Effect Level-Administrative Regulations" and "Product Classification-Medical Devices", the system can quickly narrow the search scope to a set of regulations that meet these two conditions, avoiding blind searches in massive regulations and greatly saving search time; on the other hand, it quickly obtains commonly used regulations. Specifically, the practical classification selection page groups and displays commonly used options according to the various stages in the entire product compliance process. When users need to find regulations related to commonly used matters in a specific stage, such as the "registration unit division" in the registration stage, they only need to directly select the commonly used option, and the system can quickly locate and display a list of relevant regulations without the user having to sort out and enter complex search conditions, thereby improving search efficiency.

[0118] 2. Enhanced search accuracy. Specifically, users can select category options or common items with a simple click, without requiring specialized search knowledge and skills. This intuitive operation lowers the barrier to entry, making it easy for users of all levels to get started and improving the user experience. Furthermore, users can freely combine multiple category options on the precise search page to search based on their needs and preferences, or directly select the common items option on the practical category selection page for a quick search. This personalized search method meets the diverse needs of different users, enabling users to more efficiently obtain the required regulatory information.

[0119] According to an embodiment of the present disclosure, the list items in the regulations list are used to display basic attribute information of the corresponding regulations; wherein the basic attribute information includes: regulation title, original document number, issuing agency, issuing date and effective date.

[0120] In addition, the list items in the regulations list are also used to display the corresponding stages and content summary information of the corresponding regulations; wherein the corresponding stages include at least one of the following stages: innovation and research and development, product testing, clinical evaluation, registration and filing, production, operation, use, supervision and inspection, and the content summary information includes: purpose and significance information, scope of application information, regulatory agency information, regulatory object information, regulatory description information, how to implement information and when to take effect information. wherein, the purpose and significance information is used to describe the purpose and significance of the regulatory agency in formulating the corresponding regulations, the scope of application information is used to describe the subjects and / or geographical scope involved in the corresponding regulations, and the subjects include at least one of activities, content, and products; the regulatory agency information is used to describe the administrative agency and / or regulatory agency and / or the geographical scope under the jurisdiction of the corresponding regulations, the regulatory object information is used to describe the regulated object and / or the geographical scope involved, the regulatory description information is used to describe the summary content and directory of the corresponding regulations, the how to implement information is used to describe the steps, procedures and time of supervision, and the when to take effect information is used to describe the effective date of the corresponding regulations.

[0121] In this disclosure, a unique content summary function is provided for each regulation. Starting from the seven aspects of reason (WHY), object (WHAT), place (WHERE), time (WHEN), personnel (WHO), method (HOW), and scope of application (SCOPE), the regulatory information is parsed using the 5W1H1S (What, Why, Who, Where, When, How, Scope) analysis method, and compiled into a content summary to facilitate users to quickly understand. In specific implementation, the corresponding content summary information can be obtained by searching for the specified chapter content in the regulatory content based on the keywords corresponding to each content summary information. For example: search for the clauses recorded in the legislative purpose chapter in the regulatory content based on keywords related to purpose and significance, extract sentences describing the purpose and significance of the regulatory agency in formulating this regulation, and obtain the purpose and significance information in the content summary.

[0122] This disclosure compulsorily covers the core elements of regulations through 5W1H1S, avoiding the subjective arbitrariness of manual summaries. In addition, users do not need to read the entire text; they can judge the relevance of regulations and quickly locate key information through summaries. Therefore, through structured analysis and scenario-based presentation, the time it takes for users to obtain core information is significantly shortened, compliance efficiency is improved, and key elements (such as effective date and scope of application) are not missed, effectively controlling compliance risks.

[0123] In addition, the regulations interface also includes a keyword search control group, which includes a keyword search range selection control and a keyword input control. The keyword search range selection control is used to provide selectable keyword search ranges, such as the regulation title and original document number, and the keyword input control is used to receive keywords entered by the user. In response to the user's selection of the keyword search control group and the entered keyword, a corresponding regulation list is displayed.

[0124] Figure 5 FIG. 1 is a flowchart of another method for assisting medical device product compliance according to an embodiment of the present disclosure. Figure 5 As shown, in addition to the above steps S110 to S130, the simulation and evaluation method further includes the following steps S140 to S150:

[0125] In step S140, an administrative approval matter selection interface is displayed, which includes multiple matter groups, each of which corresponds to a plurality of stages in the entire product compliance process, and the matter group includes administrative approval matter options in the corresponding stage.

[0126] In step S150, in response to the user's selection of any administrative approval matter option in the administrative approval matter selection interface, the corresponding administrative approval matter description page is displayed, and the administrative approval matter description page includes: an application basis page, an application materials page, a process and time limit page, an approval result page and an attachment download page; the application basis page includes a corresponding list of regulations; wherein, the corresponding list of regulations included in the application basis page is obtained by using a keyword retrieval determined based on the user's selection of any administrative approval matter option in the administrative approval matter selection interface.

[0127] Among them, administrative approval matters refer to the key compliance nodes that medical device companies must apply for and obtain approval from regulatory agencies in the entire process of product compliance. They are legally mandatory, stage-related and standardized processes. Among them, legal mandatory is reflected in: according to the "Medical Device Supervision and Administration Regulations" and other regulations, no subsequent activities may be carried out without approval (such as sales without a registration certificate); stage-related is reflected in: each matter corresponds to a specific product compliance full process stage (such as "product registration" belongs to the "registration and filing" stage); standardized process is reflected in: fixed materials must be submitted and clear time limits must be followed. Each administrative approval matter has a unique corresponding product compliance full process stage. The inventors of this disclosure have sorted out the administrative approval matters involved in each stage of the medical device product compliance full process in detail to form an administrative approval matter library. Table 3 shows the administrative approval matters involved in each stage of the product compliance full process and their correspondence with the stage number. When specifically associating regulations with specific administrative approval matters, only the administrative approval matters corresponding to the selected product compliance full process stage can be selected. For example, if a guideline selects "Product Inspection," "Clinical Evaluation," and "Registration and Filing" as the product compliance process stages, then only all administrative approval items within these three product compliance process stages can be selected. For example, "Product Registration" is selectable, while "Classification Definition," as part of other product compliance process stages, is not selectable. It should be noted that the specific administrative approval item classifications shown in Table 3 are merely a specific classification method adapted to the current product compliance process. The correspondence described in Table 3 may change with changes in regulations and requires timely updates.

[0128] Table 3 Administrative approval matters involved in each stage of the product compliance process and their corresponding relationship with the stage number

[0129]

[0130]

[0131] In the present disclosure, when the backend server or designated device categorizes and labels regulations based on their content within a regulatory document, it also includes a process for associating regulations with administrative approval matters. Specifically, each regulation is analyzed to determine which administrative approval matters it is associated with. For example, a regulation regarding product attribute definition might be labeled as being associated with the administrative approval matter of "product attribute definition." The associated data between the regulation and the administrative approval matter is then stored in the regulatory database. When a user selects any administrative approval matter option, the system records the user's selection, including the name or unique identifier of the selected administrative approval matter. Based on the selected administrative approval matter, the system then extracts keywords related to the matter from pre-established association information between administrative approval matters and regulations. These keywords can include the name of the administrative approval matter, related keywords, etc. The extracted keywords are then combined to form a keyword combination for searching for regulations. Next, a database query statement is constructed based on the determined keyword combination. The constructed query statement is sent to the regulatory database to execute the query. The database management system then matches the query statement against the regulatory information table and returns regulatory records that meet the criteria.

[0132] Figure 6 Schematic diagram of the specific implementation of the administrative approval matters selection page according to the embodiment of the present disclosure is shown. Figure 6 As shown, in each stage, the specific administrative approval matters involved in the corresponding stage are clearly listed, so that users can click and enter the administrative approval matter description page to view the content related to a specific administrative approval matter in the corresponding stage.

[0133] Figure 7 A schematic diagram illustrating a specific implementation of an administrative approval matter description page according to an embodiment of the present disclosure is shown. Figure 7 Only describe the specific page name contained in the administrative approval matters description page, and the content name part contained in the corresponding specific page. Figure 7As shown, after entering the administrative approval item description page, the default display is the "Application Basis Page" related to the specific administrative approval item. In the application basis page, the content included is divided into the following parts: item name, scope of application, handling basis, acceptance agency, implementation agency and charging standards. Among them, the regulations involved in the specific administrative approval item at the corresponding stage are included in the "Handling Basis" section and presented in the form of a list. Different from the regulatory details displayed in the regulations list displayed in the regulations interface, the details displayed for each regulation in the regulations list corresponding to the administrative approval item description page include but are not limited to: legal level, original document number, regulation title and effective date. If you want to view other pages related to a specific administrative approval item, such as the application materials page, you can click the corresponding page label on the administrative approval item description page to enter the corresponding page details. Among them, the application materials page includes the types and form requirements of application materials related to a specific administrative approval matter and other precautions; the process and time limit page displays the flow chart and licensing procedures related to a specific administrative approval matter. The flow chart user will visually display the entire process of a specific administrative approval matter from application to obtaining the certificate in the form of a process, and the time limit and results are clear at a glance; the approval result page displays the approval standards, required approval certificates, license validity and complaint channel information related to a specific administrative approval matter; the attachment download page provides relevant attachment download information on application documents, application materials, processes and time limits related to a specific administrative approval matter.

[0134] In addition, the administrative approval matter description page also includes a related question summary page. On this related question summary page, questions raised by other users related to a specific administrative approval matter and that already have answers are listed for the current user's reference. Users can view specific questions and corresponding answers to prevent similar problems from occurring.

[0135] In this disclosure, the technical and business significance of administrative approval matters corresponding to each stage is reflected in:

[0136] 1. Value at the technical implementation level. Users can quickly locate an item through the hierarchical relationship between stage and administrative approval (e.g., selecting "Clinical Evaluation → Clinical Trial Registration"), avoiding blind searches across hundreds of approvals and achieving precise navigation. By integrating all the necessary information for the approval (such as the process and time limit, and the approval result) on each item page, this solves the traditional problem of requiring cross-domain searches across multiple government websites and achieves data aggregation.

[0137] 2. Value in business compliance. By ensuring that approval requirements at each stage are not missed (for example, the "clinical trial approval" or "clinical trial filing" must be completed during the "clinical evaluation stage"), a closed-loop compliance system is achieved. By clearly demarcating the interaction points between companies (sponsors) and regulatory agencies (for example, the registration stage requires submission of materials to relevant departments, and the production stage requires cooperation with provincial bureaus for on-site inspections), responsibilities are clearly defined.

[0138] 3. Improved user efficiency. The application information page automatically generates a list of documents (such as a registration test report template), and the process and time limit page graphically displays the time required for each step of "acceptance → technical review → administrative approval", thereby supporting one-stop processing and significantly improving user efficiency. In addition, the approval result page displays common reasons for rejection (such as "inadequate clinical data") to help companies avoid problems in advance.

[0139] According to an embodiment of the present disclosure, in addition to displaying a product compliance full-process stage selection interface and an administrative approval item selection interface, the method further includes: displaying an intelligent recommendation interface, wherein the intelligent recommendation interface includes an intelligent recommendation control. When a user clicks the "intelligent recommendation" control, a recommendation list is displayed in response to the user's selection of the intelligent recommendation control, allowing the user to quickly jump to the recommended stage or regulation interface to view the stage or regulation of interest. When generating the recommendation list content, the user's historical access records are first obtained, including information such as the compliance stages previously visited by the user, the regulatory categories viewed, the keywords searched, the duration of stay on these pages, and click behavior. Then, based on the current product type and compliance requirements, combined with the user's historical access records, key features are extracted to generate a user profile. When generating the user profile, based on the extracted key features, data mining techniques such as cluster analysis and association rule mining are used to classify and profile the user. For example, based on the frequency of users' visits to different product types and compliance stages, users are divided into different groups, such as users focusing on medical device R&D and users focusing on pharmaceutical production compliance. At the same time, a detailed user profile is generated for each user, including the user's basic information, interests, preferences, and behavior patterns. Then, a collaborative filtering algorithm or a content-based recommendation algorithm is used to generate a recommendation list based on the user portrait. The recommendation list may include the recommended stage, regulatory category, and corresponding common matters and administrative approval matters.

[0140] In one specific embodiment, after a user enters product information (such as product name and type) in the intelligent recommendation interface, the user can also predict the subsequent stage and the corresponding regulations, common matters, and administrative approval matters based on the entered product information and historical access records. Specifically, a predictive model is first constructed and trained. When selecting a predictive model, an appropriate model can be selected based on the requirements of the prediction task. Common predictive models include decision trees, random forests, and neural networks. In this scenario, since multiple related information such as subsequent stages, regulations, common matters, and administrative approval matters need to be predicted, a multi-task learning model or an ensemble learning model can be used. When annotating historical access data, the user's access records are associated with the actual subsequent compliance stages and regulations. The annotated data is then divided into training, validation, and test sets for model training, tuning, and evaluation. When training the selected predictive model using the training set, the model parameters are continuously adjusted to enable the model to learn the potential relationships between product information, historical access records, and subsequent compliance stages and regulations. During the training process, the validation set is used to monitor and tune the model's performance in real time to prevent overfitting.

[0141] When a user enters product information in the smart recommendation interface, the system feeds that information into a trained prediction model. Based on the input product information and user profile, the model predicts the subsequent compliance stages that the user may be interested in or that are suitable for the current product. Based on the predicted subsequent compliance stage, the model further combines product information and user profile to predict the regulations, common issues, and administrative approval matters related to that stage. For example, if the subsequent stage is predicted to be the medical device registration stage, the model will recommend relevant medical device registration regulations, a list of materials required for registration (common issues), and the registration approval process and timeline (administrative approval matters).

[0142] In addition to compliance phases, regulations, common matters, and administrative approval items, the model can also predict other relevant information that users may be interested in based on their historical access history and product information, such as industry trends, policy interpretations, and case studies. Finally, the predicted subsequent phases, regulations, common matters, administrative approval items, and other information are integrated into a recommendation list. When generating the recommendation list, the information can be sorted based on user preferences and importance, with the most relevant and valuable information at the top, allowing users to quickly find what they need. Furthermore, while users are viewing the recommendation list, user feedback can be collected, such as click-through rate, browsing time, and bookmarking of recommended content. This feedback can be used to evaluate the effectiveness of recommendations and provide a basis for subsequent model optimization. During model optimization, the prediction model can be regularly evaluated and optimized based on user feedback. If the model's prediction performance is found to be poor, model parameters can be adjusted, training data can be added, or a more appropriate model algorithm can be adopted to improve the accuracy and personalization of recommendations.

[0143] By providing an intelligent recommendation function, the present disclosure has the following beneficial technical effects:

[0144] 1. Improved operational convenience and efficiency. On the one hand, it allows users to quickly locate the content they need. This is particularly evident in the fact that medical device product compliance involves numerous complex stages and a vast number of regulations. Finding the stages or regulations of interest on their own often requires considerable time and effort. The intelligent recommendation interface generates a list of recommendations based on the user's historical operation history and current product status. Users can directly view content of potential interest by clicking the "Intelligent Recommendation" control, eliminating the need to blindly search through numerous interfaces and options. This significantly saves time and steps, improving user efficiency. On the other hand, it provides a personalized service experience. This is particularly evident in the fact that different users have different requirements for compliance stages and regulations due to their product type, business scope, and work focus. The intelligent recommendation interface provides personalized recommendations based on user profiles, tailoring a list of recommendations to each user's specific needs. This provides a personalized service experience, increasing user satisfaction and loyalty. It also reduces learning costs and user experience. This is particularly evident in the fact that new users to medical device product compliance may find the complex compliance process and numerous regulations overwhelming. The intelligent recommendation interface can recommend basic compliance stages and common regulations based on common problems and initial needs that novice users may face, helping novices get started quickly, reducing learning costs, and enabling them to carry out compliance work more smoothly.

[0145] 2. Adaptability to complex scenarios. Compliance scenarios in the medical device industry are complex and ever-changing, with different products facing varying compliance requirements across various stages of development, production, and sales. The intelligent recommendation interface makes recommendations based on the current product type and compliance requirements, providing users with precise guidance in different scenarios. Even when faced with complex compliance issues, users can find relevant phases and regulatory references in the recommended list, simplifying usage.

[0146] 3. Enhance the comprehensiveness and accuracy of information acquisition. When users search for regulations on their own, they may miss important stages or regulations due to negligence or unfamiliarity with the compliance system. The intelligent recommendation interface comprehensively analyzes the user's historical operations and current product status, comprehensively considering various possible compliance needs, providing users with a wider range of recommended content, helping users discover important information that they may have overlooked, avoiding information omissions, and ensuring comprehensive compliance work.

[0147] 4. Provide accurate information. User profiles generated using collaborative filtering or content-based recommendation algorithms accurately capture user interests and preferences. The recommended lists, including phases, regulatory categories, and corresponding common matters and administrative approval items, are precisely matched to the user profile, providing users with highly relevant information, improving the accuracy of information acquisition, and enabling them to more accurately carry out compliance work.

[0148] Figure 8 FIG. 1 shows a structural block diagram of a medical device product compliance auxiliary device according to an embodiment of the present disclosure. Figure 8As shown, the device 800 includes: a product compliance full process stage selection module, which is configured to: display a product compliance full process stage selection interface, the product compliance full process stage selection interface includes multiple control groups, the multiple control groups respectively correspond to multiple stages in the product compliance full process, and the control groups include regulatory summary controls and other related information controls for the corresponding stages; a regulatory interface display module, which is configured to: respond to a user's selection operation on any regulatory summary control, display a regulatory interface for the corresponding stage, the regulatory interface includes a regulatory list for the corresponding stage, and also includes a precise query page and / or a practical classification selection page, the precise query page includes multiple option sets, each option set includes multiple different category options in a corresponding regulatory classification method, The regulation classification method includes: legal effect level, product classification, product supervision category, and legislative stage. The practical classification selection page includes multiple option groups, and the multiple option groups correspond to multiple stages in the entire product compliance process, and the option groups include common matters options in the corresponding stages; the regulation list generation module is configured to: display the corresponding regulation list in response to the user's selection of any one or more category options in the precise query page, or the selection of any common matters option in the practical classification selection page; wherein, the corresponding regulation list is obtained by keyword retrieval based on the user's selection of any one or more category options in the precise query page, or the selection of any common matters option in the practical classification selection page.

[0149] According to an embodiment of the present disclosure, the apparatus 800 further includes: an administrative approval matter processing module; the administrative approval matter processing module includes: an administrative approval matter selection module and an administrative approval matter description module; wherein:

[0150] The administrative approval matter selection module is configured to: display an administrative approval matter selection interface, the administrative approval matter selection interface includes multiple matter groups, the multiple matter groups respectively correspond to multiple stages in the product compliance process, and the matter groups include administrative approval matter options in the corresponding stages; the administrative approval matter description module is configured to: respond to the user's selection of any administrative approval matter option in the administrative approval matter selection interface, display the corresponding administrative approval matter description page, the administrative approval matter description page includes: application basis page, application materials page, process and time limit page, approval result page and attachment download page; the application basis page includes a corresponding list of regulations; wherein the corresponding list of regulations included in the application basis page is obtained by keyword retrieval based on the user's selection of any administrative approval matter option in the administrative approval matter selection interface.

[0151] According to an embodiment of the present disclosure, the device also includes: an intelligent recommendation module, which is configured to: display an intelligent recommendation interface, the intelligent recommendation interface including an intelligent recommendation control, and display a recommendation list in response to a user's selection operation on the intelligent recommendation control.

[0152] Figure 9 FIG. 1 shows a structural block diagram of an electronic device according to an embodiment of the present disclosure. Figure 9 As shown, the electronic device includes a memory and a processor; wherein the memory is used to store one or more computer instructions, wherein the one or more computer instructions are executed by the processor to implement the method described in any one of the above method embodiments.

[0153] The present disclosure also provides another electronic device, comprising the device described in any one of the above device embodiments.

[0154] The present disclosure also provides a computer-readable storage medium, which can be included in the electronic device or computer system described in the above embodiments, or can be a standalone computer-readable storage medium not incorporated into the device. The computer-readable storage medium stores one or more programs, which are used by one or more processors to execute the methods described in the present disclosure.

[0155] The present disclosure further provides a computer program product, comprising a computer program, which implements any of the methods described in the present disclosure when the computer program is executed by a processor.

[0156] The technical solutions provided by the disclosed embodiments innovatively divide the entire medical device development to delisting process into multiple key stages. This restructures the traditional fragmented compliance management model through a "full product compliance process" perspective, integrating functional modules such as regulatory inquiries and common issues guidance into each stage to form a structured compliance management framework. This avoids the problems inherent in traditional compliance work, significantly improving the standardization, accuracy, and timeliness of compliance work for medical device companies, reducing compliance risks, and accelerating product launches.

[0157] The above description is merely a preferred embodiment of the present disclosure and an illustration of the technical principles employed. Those skilled in the art should understand that the scope of the invention herein is not limited to the technical solutions formed by the specific combination of the above-mentioned technical features, but also encompasses other technical solutions formed by any combination of the above-mentioned technical features or their equivalents without departing from the inventive concept. For example, a technical solution formed by replacing the above-mentioned features with (but not limited to) technical features with similar functions disclosed in this disclosure.

Claims

1. A medical device product compliance assistance method, characterized in that: The method comprises: Displaying a product compliance full process stage selection interface, the product compliance full process stage selection interface includes multiple control groups, each of which corresponds to a multiple stage in the product compliance full process, and the control group includes a regulatory summary control and other related information controls for the corresponding stage; In response to a user's selection of any regulatory summary control, a regulatory interface for the corresponding stage is displayed. The regulatory interface includes a list of regulations for the corresponding stage, a precise query page, and / or a practical classification selection page. The precise query page includes multiple option sets, each option set including multiple different category options in a corresponding regulatory classification method. The regulatory classification methods include: legal effect level, product classification, product supervision category, and legislative stage. The practical classification selection page includes multiple option groups, each of which corresponds to multiple stages in the full product compliance process, and includes options for commonly used items in the corresponding stage. In response to the user's selection of any one or more category options in the precise query page, or the selection of any common matters option in the practical classification selection page, a corresponding list of regulations is displayed; wherein, the corresponding list of regulations is retrieved using keywords determined based on the user's selection of any one or more category options in the precise query page, or the selection of any common matters option in the practical classification selection page.

2. The method according to claim 1, characterized in that The multiple control groups include: innovation and development control group, product inspection control group, clinical evaluation control group, registration and filing control group, production control group, operation control group, usage control group, and supervision and inspection control group.

3. The method according to claim 2, characterized in that Other related information controls of the innovation and development control group include: innovative product catalog control, which is used to provide the catalog of innovative public products and the catalog of approved innovative products; priority product catalog control, which is used to provide the catalog of priority products; innovation and priority product review report summary control, which is used to provide the innovation and priority product review report; Other related information controls of the product inspection control group include: inspection display control, which is used to display relevant information of the standard technical committee; industry standard full text disclosure system control, which is used to index the currently valid mandatory industry standards, recommended industry standards and download the collected guiding technical documents; Other related information controls of the clinical evaluation control group include: clinical trial information query control, which is used to provide a clinical trial information query page and a clinical trial information display page; clinical-free IVD reagent product catalog control, which is used to provide a clinical-free IVD reagent product catalog; Other related information controls of the registration and filing control group include: a review report information summary control, which is used to provide a summary of the review report information; a registration technical review guideline summary control, which is used to provide a summary of the registration technical review guideline; Other related information controls of the production control group include: a daily record of prohibited commissioned production control, which is used to provide a daily record of prohibited commissioned production; a production key supervision catalog control, which is used to provide a production key supervision catalog; Other related information controls of the business control group include: a key business supervision catalog control, which is used to provide a key business supervision catalog; a recalled product list control, which is used to provide a recalled product list; Other related information controls of the control group include: a quality supervision announcement control, which is used to publish official quality announcements; and an adverse event information control, which is used to provide adverse event information.

4. The method according to claim 1, wherein The method further comprises: Displaying an administrative approval item selection interface, the administrative approval item selection interface including multiple item groups, each of which corresponds to a plurality of stages in the product compliance process, and the item group includes administrative approval item options in the corresponding stage; In response to the user's selection of any administrative approval matter option in the administrative approval matter selection interface, the corresponding administrative approval matter description page is displayed, and the administrative approval matter description page includes: an application basis page, an application materials page, a process and time limit page, an approval result page and an attachment download page; the application basis page includes a corresponding list of regulations; wherein, the corresponding list of regulations included in the application basis page is obtained by keyword retrieval based on the user's selection of any administrative approval matter option in the administrative approval matter selection interface.

5. The method according to claim 1, wherein For the category options in each regulatory classification method, the category options corresponding to the legal effect level include: laws, administrative regulations, departmental regulations, normative documents, announcements, working documents, technical guidelines and review points; the category options corresponding to the product classification include: domestic Class I, domestic Class II, domestic Class III, overseas Class I, overseas Class II and overseas Class III; the category options corresponding to the product supervision category include: medical devices, in vitro diagnostic reagents, in vitro diagnostic reagents under drug management, drug-device combination products and inactive medical devices; the category options corresponding to the legislative stage include: formal draft, draft for solicitation and repealed.

6. The method according to claim 1, characterized in that The regulatory interface further includes a keyword query control group, which includes a keyword query range selection control and a keyword input control, wherein the keyword query range selection control is used to provide a selectable keyword query range, and the keyword input control is used to receive a keyword input by a user; In response to the user's selection of the keyword query control group and the keyword input, a corresponding list of regulations is displayed.

7. The method according to claim 1, characterized in that The list items in the regulations list are used to display the basic attribute information of the corresponding regulations; wherein the basic attribute information includes: regulation title, original document number, issuing agency, issuing date and effective date.

8. The method according to claim 7, characterized in that The list items in the regulations list are also used to display the corresponding stages and content summary information of the corresponding regulations; wherein, the corresponding stages include at least one of the following stages: innovation and research and development, product inspection, clinical evaluation, registration and filing, production, operation, use, supervision and inspection, and the content summary information includes: purpose and significance information, scope of application information, regulatory agency information, regulatory object information, regulatory description information, implementation information and effective time information.

9. A medical device product compliance auxiliary device, characterized in that: The device comprises: The product compliance full-process stage selection module is configured to: display a product compliance full-process stage selection interface, wherein the product compliance full-process stage selection interface includes multiple control groups, each of which corresponds to a plurality of stages in the product compliance full-process, and each control group includes a regulatory summary control and other relevant information controls for the corresponding stage; A regulatory interface display module is configured to: in response to a user selecting any regulatory summary control, display a regulatory interface for the corresponding stage, the regulatory interface including a list of regulations for the corresponding stage, a precise query page, and / or a practical classification selection page, the precise query page including multiple option sets, each option set including multiple different category options from a corresponding regulatory classification method, the regulatory classification methods including: legal effect level, product classification, product supervision category, and legislative stage, the practical classification selection page including multiple option groups, each of which corresponds to multiple stages in the full product compliance process, and each option group includes options for commonly used items in the corresponding stage; The regulations list generation module is configured to: display a corresponding regulations list in response to a user's selection of any one or more category options in the precise query page, or a selection of any commonly used items option in the practical classification selection page; wherein the corresponding regulations list is retrieved using keywords determined based on the user's selection of any one or more category options in the precise query page, or a selection of any commonly used items option in the practical classification selection page.

10. The device according to claim 9, characterized in that The device further comprises: an administrative approval matter processing module; the administrative approval matter processing module comprises: an administrative approval matter selection module and an administrative approval matter description module; wherein: The administrative approval item selection module is configured to: display an administrative approval item selection interface, wherein the administrative approval item selection interface includes multiple item groups, each of which corresponds to a plurality of stages in the product compliance process, and each item group includes administrative approval item options in the corresponding stage; The administrative approval matter description module is configured to: in response to the user's selection of any administrative approval matter option in the administrative approval matter selection interface, display the corresponding administrative approval matter description page, the administrative approval matter description page including: application basis page, application materials page, process and time limit page, approval result page and attachment download page; the application basis page includes a corresponding list of regulations; wherein, the corresponding list of regulations included in the application basis page is retrieved using keywords determined based on the user's selection of any administrative approval matter option in the administrative approval matter selection interface.

11. An electronic device, characterized in that: A device comprising any one of claims 9 to 10; or comprising a memory and a processor; wherein the memory is used to store one or more computer instructions, wherein the one or more computer instructions are executed by the processor to implement the method according to any one of claims 1 to 8.

12. A computer-readable storage medium having computer instructions stored thereon, characterized in that: When the computer instructions are executed by a processor, the method according to any one of claims 1 to 8 is implemented.

13. A computer program product comprising a computer program, characterized in that When the computer program is executed by a processor, the method according to any one of claims 1 to 8 is implemented.

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