Medical instrument registration full-process collaborative management system based on local deployment
Through locally deployed modular design and distributed microservice architecture, the lack of standardization and security issues in the traditional medical device registration process are resolved, and efficient and secure medical device registration management is achieved.
Patent Information
- Application Number
- CN202510915671.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-03
- Publication Date
- 2025-09-23
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Traditional medical device registration process management relies on a manual collaboration model, lacks a standardized framework, has loose process connections, out-of-control document versions, insufficient security, and difficulty in tracking progress, which cannot meet the strict compliance requirements of the medical device industry.
A modular design based on local deployment is adopted to achieve standardized disassembly of medical device registration tasks, refined permission control, standardized document management and intelligent early warning. Combined with a distributed microservice architecture and two-factor authentication, a multi-layer security system is built, providing structured document templates and visual progress display.
It improves the efficiency of medical device registration, ensures data security, realizes process standardization and visual management, and meets the compliance requirements of the medical device industry.
Smart Images
Figure CN120690407A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical device registration management, and in particular to a collaborative management system for the entire process of medical device registration based on local deployment. Background Art
[0002] In the field of medical device registration management, traditional registration process management relies heavily on manual collaboration or decentralized system management, and faces many technical bottlenecks that need to be addressed. Specifically, the decomposition and allocation of registration tasks lacks a standardized framework, resulting in loose and disordered connections between various business links, inefficient process collaboration, and difficulty in tracking progress. The electronic documents generated during the registration process lack unified structured template specifications, and their storage methods are scattered and chaotic, which can easily lead to document version loss, content omissions, or compliance risks. Existing management systems generally lack automated time warning mechanisms, and the monitoring of task deadlines relies entirely on manual reminders, making it difficult to avoid registration process timeouts. Some systems use cloud deployment or open network access modes, with crude and simple user authority control systems. The security of data transmission and storage cannot be effectively guaranteed, which seriously fails to meet the strict compliance requirements of the medical device industry. At the same time, the overall progress of the registration process lacks intuitive and visual display methods, and managers cannot grasp the completion status of tasks in each sub-stage in real time, making it difficult to carry out scientific resource allocation and risk prediction.
[0003] In view of this, the present invention proposes a collaborative management system for the entire process of medical device registration based on local deployment. Through innovative modular design, it realizes the standardized disassembly of medical device registration tasks, refined authority hierarchical control, standardized document template management and intelligent dynamic early warning, fundamentally improving the efficiency of medical device registration and comprehensively ensuring data security. Summary of the Invention
[0004] The purpose of the present invention is to provide a collaborative management system for the entire process of medical device registration based on local deployment to solve the problems raised in the above background technology.
[0005] In order to solve the above technical problems, the present invention provides the following technical solutions: A collaborative management system for the entire medical device registration process based on local deployment, including a user interaction module, a registration process management module, a notification module, a document management module, and an administrator module; The user interaction module is used to register a user account and configure operation permissions for the registered user account. Based on the operation permissions of the user account, the user account performs process operations on the registration process sub-stages that match the operation permissions, and generates registration process electronic documents corresponding to the registration process sub-stages; The registration process management module is used to receive medical device registration tasks, break down the medical device registration tasks into a sequence of registration process sub-stages, and assign each registration process sub-stage in the sequence of registration process sub-stages to a user account with the required operation authority to wait for process operations; The notification module is used to preset time nodes for each registration process sub-stage and record in real time the deadline for the user account to complete the process operation of the registration process sub-stage that matches the operation authority. Based on the time nodes and deadlines, it performs hierarchical notification and warning, and displays the progress of the medical device registration task; The document management module is used to provide a registration process electronic document template corresponding to each registration process sub-stage in the registration process sub-stage sequence for process operations, and store the registration process electronic documents corresponding to the registration process sub-stage according to the medical device registration task; The administrator module is used to upload medical device registration tasks to the registration process management module and export registration process electronic documents from the document management module, and at the same time perform addition, deletion and query operations on user accounts in the user interaction module.
[0006] Preferably, the user interaction module, registration process management module, notification module, document management module and administrator module are all deployed on the Dell PowerEdge R740 physical server cluster of the enterprise's internal LAN using a distributed microservice architecture, and are physically isolated from the external network in three layers by a Cisco ASA 5585-X firewall. The locally deployed full-process collaborative management system for medical device registration builds an intranet authentication system based on the LDAP v3 lightweight directory service protocol, and is deeply integrated with the Active Directory domain service. Users need to complete identity verification through a two-factor authentication of Time-based One-Time Password dynamic password and fingerprint recognition. The authentication process follows the RFC6749 specification of the OAuth 2.0 authorization framework, and fine-grained permission hierarchical management is achieved through Bearer Token. For external network access, only a connection is allowed through a Juniper SRX340 VPN gateway that supports the SSL / TLS 1.3 encryption protocol. The VPN link uses the AES-256-GCM advanced symmetric encryption algorithm for data transmission encryption, where the key length is 256. The system automatically rotates every 15 minutes and deploys the Snort intrusion detection system and the Suricata intrusion prevention system. The system monitors the malicious code characteristics and abnormal access behaviors in network traffic in real time based on the YARA rule engine. The AES-256-GCM encryption algorithm is an advanced symmetric encryption algorithm used to encrypt transmitted data; The OAuth 2.0 authorization framework is a token-based authorization framework; The YARA rule engine is an open source tool for detecting and classifying malicious code. Its core function is to identify and warn of threats by matching specific features in files or network traffic through custom rules. The LDAP v3 lightweight directory service protocol is an application layer protocol for accessing and maintaining distributed directory information services.
[0007] Preferably, a user interaction module of a locally deployed full-process collaborative management system for medical device registration includes a user registration unit, a permission configuration unit, an approval unit, an audit unit, an audit judgment unit, and a registration submission unit; The user registration unit is used to obtain the account identity information submitted by the user through the front-end form, specifically including the user name, password, telephone number, email number, role, affiliated organization and the telephone number of the person in charge of the affiliated organization, wherein the password is encrypted and stored using the SHA-256 hash algorithm in combination with a 128 random salt value, the salt value is generated by an encryption secure pseudo-random number generator and stored in a security field of the distributed database MongoDB in a specific format with the hash value, the account identity information verification process includes data format verification, uniqueness check and OCR recognition verification of the affiliated organization's qualification documents, the data format verification is carried out through regular expression matching, the uniqueness check is carried out through a joint query of the Redis cache and the database, the OCR recognition verification of the affiliated organization's qualification documents uses the Tesseract OCR engine combined with a customized medical device industry vocabulary to extract key fields from the business license, and performs real-time comparison with the National Enterprise Credit Information Publicity System API, and the blockchain smart contract built on Hyperledger Fabric is called for the verified account identity information to be stored on the chain and then a user account is generated; Hyperledger Fabric is an enterprise-grade consortium chain open source framework designed for distributed ledger applications running in a permissioned network environment; The permission configuration unit is used to construct a permission control matrix based on the role-based access control model, dividing user accounts into registration specialist accounts, review expert accounts and approval leader accounts. The registration specialist account is associated with the operation permission of the registration submission sub-stage, that is, the medical device registration submission right, including the permission to retrieve and edit the medical device registration application form template, technical document template and test report template. The review expert account is associated with the operation permission of the review sub-stage, that is, the review right, including the permission to review and annotate the electronic documents of the registration process generated in the registration submission sub-stage and to call and edit the medical device review form template. The approval leader account is associated with the operation permission of the approval sub-stage, with the permission to call the medical device approval form template and sign the final approval conclusion; The registration submission unit is used to allow the registration specialist account to retrieve the corresponding medical device registration application form template, medical device technical document template, and medical device test report template through the workflow engine during the registration submission sub-stage. The medical device application form template integrates a data linkage function. After editing is completed, the system automatically performs format verification and generates a PDF document with a timestamp. At the same time, the medical device review form generated by the review unit in the review sub-stage is received through the message queue; The review unit is used to allow the review expert account to make online annotations on the documents generated by the registration submission unit, including the medical device registration application form, medical device technical documents, and medical device test reports, through the document collaborative editing platform during the review sub-stage. The called medical device review form template includes mandatory item verification. If the review conclusion is that modification is required, the document rollback process is automatically triggered. The system generates a modification task list containing the review opinions and pushes it to the registration specialist account; The audit judgment unit is used to execute state machine logic based on the audit conclusion in the medical device audit form. When the audit conclusion is passed, the medical device audit form is automatically packaged into the approval sub-stage task package and submitted to the approval unit for approval. When the conclusion is not passed, a rejection reason opinion containing the audit opinion is generated and pushed to the registration specialist account; The approval unit is used to allow the approval leader account to call the medical device approval form template containing an anti-counterfeiting watermark in the approval sub-stage. When editing the approval conclusion, two-factor authentication including a dynamic password and fingerprint recognition is required. After the approval is passed, the system automatically generates a medical device approval form with an electronic seal, and synchronizes the results to the review unit and the registration submission unit through the Webhook interface.
[0008] Preferably, the process operation in which the user account performs process operations on the registration process sub-stage that matches the operation authority refers to the user account that plays each role completing the process operations that meet the scope of operation authority in the corresponding registration process sub-stage through the template call, document editing, electronic signature and status flow function interface provided by the system.
[0009] Preferably, in the registration process management module, the process of breaking down the medical device registration task into a sequence of registration process sub-stages is as follows: The preset standard process framework for medical device registration is a structured process model based on the "Medical Device Registration Management Measures" issued by the National Medical Products Administration, combined with the ISO 13485 medical device quality management system standard and industry best practices. By breaking down the statutory links stipulated in the "Medical Device Registration Management Measures" into digitally manageable registration process sub-stages, and using BPMN 2.0 to abstract the common links of the digitally manageable registration process sub-stages, a standard process framework for medical device registration is obtained; Automatically decompose medical device registration tasks into a sequence of registration process sub-stages, including registration submission sub-stage, review sub-stage, and approval sub-stage, through the preset standard process framework for medical device registration. Each registration process sub-stage is associated with specific operation permissions, document templates, and time node requirements. BPMN 2.0 is a standardized business process modeling language developed by the Object Management Group (OMG) and is used to graphically represent the operational steps, logical relationships, and responsibilities of participants in a business process.
[0010] Preferably, in the notification module, the process of executing the hierarchical notification warning is: If the deadline is 3 days or more before the time node, the email address of the user account associated with the registration process sub-stage is queried through the LDAP directory service, and the SMTP protocol interface is called to generate a notification email to notify the user to whom the user account belongs; If the deadline is less than 3 days and greater than or equal to 1 day before the deadline, the LDAP directory service is used to query the phone number of the user account associated with this sub-stage of the registration process. Based on this, the operator's SMS gateway API is connected to generate a phone text message containing a dynamic verification code and notify the user to whom the user account belongs; When the deadline is less than 1 day earlier than the time node, the telephone number of the head of the organization to which the user account associated with the registration process sub-stage is queried through the LDAP directory service, the PSTN telephone automatic dialing system is called, and the TTS speech synthesis technology is used to convert the timeout notification into a voice broadcast to notify the head of the organization to which the user account belongs.
[0011] Preferably, in the registration process management module, the process of displaying the progress of the medical device registration task: An interactive Gantt chart was constructed using the D3.js data visualization framework. The progress of the registration process sub-stage sequence of the medical device registration task was displayed in two dimensions, with the timeline as the horizontal axis and the registration process sub-stage sequence as the vertical axis. The registration process sub-stages in the registration process sub-stage sequence that had not completed the process operations beyond the time node were marked in red.
[0012] Preferably, the registration process electronic document template in the registration process management module is a structured document template, and the registration process electronic document template includes a medical device registration application form template, a medical device technical document template, a medical device test report template, a medical device review form template and a medical device approval form template.
[0013] Preferably, in the document management module, the process of storing the electronic documents of the registration process corresponding to the sub-stages of the registration process according to the medical device registration task is as follows: A 128-bit unique medical device registration task ID is generated using the UUID v5 algorithm combined with a timestamp. An independent storage directory with a three-level directory structure of "root directory / medical device registration task ID / registration process sub-stage / registration process electronic document" is created based on the medical device registration task ID. At the same time, a mapping relationship between the registration process sub-stage and the registration process electronic document is established through MongoDB's embedded document structure. Based on this, the registration process electronic document corresponding to the registration process sub-stage is associated and stored. The UUID v5 algorithm is a deterministic UUID generation algorithm based on name and namespace; The electronic documents of the registration process include the medical device registration application form, medical device technical documents, medical device test report, medical device review form and medical device approval form.
[0014] Preferably, a collaborative management system for the entire process of medical device registration based on local deployment also includes an administrator module, which is used to upload medical device registration tasks by calling a REST API interface that supports breakpoint resumption through a WebGL-based visual management interface, and perform a triple verification mechanism on the uploaded medical device registration tasks, including format verification, compliance verification, and data integrity verification, as well as support batch export of registration process electronic documents according to medical device registration task ID and time range, and support adding, deleting, modifying, and checking user accounts.
[0015] Due to the adoption of the above technical solution, the present invention has the following technical advancements compared to the prior art: 1. Through the standardized process framework constructed based on the "Medical Device Registration Management Measures" promulgated by the National Medical Products Administration and the ISO 13485:2016 Medical Device Quality Management System Standard, the BPMN 2.0 business process modeling language is used to automatically decompose the medical device registration task into three standardized sub-stages: registration submission, technical review, and administrative approval. Combined with the RBAC role permission control model, the operation permissions of the corresponding registration process sub-stages are configured for the registration specialist account, the review expert account, and the approval leader account. The workflow engine is used to achieve structured task assignment and cross-role collaborative operations, solving the problem of loose connection in the traditional medical device registration process.
[0016] 2. Provide a structured document template system with integrated data linkage function, including medical device registration application form template, medical device technical document template, medical device test report template, medical device review form template and medical device approval form template. Combined with UUID to generate a 128-bit unique medical device registration task ID and a three-level storage directory, it realizes document template generation and centralized management, avoids version confusion and compliance risks, and sets a hierarchical early warning mechanism based on email, SMS and phone calls based on time nodes. Combined with Gantt chart to visualize progress and mark timed links in red, it replaces manual monitoring to improve task timeliness.
[0017] 3. A distributed microservices architecture is deployed on the company's internal Dell PowerEdge R740 server cluster. A multi-layered security system is built through intranet authentication, SSL / TLS1.3 encrypted VPN, AES-256-GCM algorithm, and two-factor authentication to meet industry data security requirements. A closed-loop process is achieved with the help of the audit judgment unit state machine logic. BRIEF DESCRIPTION OF THE DRAWINGS
[0018] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments described in the present invention. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.
[0019] Figure 1 Schematic diagram of the system function modules of the present invention; Figure 2 Schematic diagram of the composition structure of the user interaction module in the system of the present invention. DETAILED DESCRIPTION
[0020] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.
[0021] Examples, such as Figure 1 The present invention relates to a collaborative management system for the entire process of medical device registration based on local deployment, which includes a user interaction module, a registration process management module, a notification module, a document management module and an administrator module, which work together to complete the collaborative management of the entire process of medical device registration.
[0022] The user interaction module is used to register a user account and configure operation permissions for the registered user account. Based on the operation permissions of the user account, the user account performs process operations on the registration process sub-stages that match the operation permissions, and generates registration process electronic documents corresponding to the registration process sub-stages; The registration process management module is used to receive medical device registration tasks, break down the medical device registration tasks into a sequence of registration process sub-stages, and assign each registration process sub-stage in the sequence of registration process sub-stages to a user account with the required operation authority to wait for process operations; The notification module is used to preset time nodes for each registration process sub-stage and record in real time the deadline for the user account to complete the process operation of the registration process sub-stage that matches the operation authority. Based on the time nodes and deadlines, it performs hierarchical notification and warning, and displays the progress of the medical device registration task; The document management module is used to provide a registration process electronic document template corresponding to each registration process sub-stage in the registration process sub-stage sequence for process operations, and store the registration process electronic documents corresponding to the registration process sub-stage according to the medical device registration task; The administrator module is used to upload medical device registration tasks to the registration process management module and export registration process electronic documents from the document management module, and at the same time perform addition, deletion and query operations on user accounts in the user interaction module.
[0023] Furthermore, the working principle of the present invention is described below by way of examples: Company C, a medical device manufacturer, deployed this system based on an internal LAN that complies with the requirements of the ISO / IEC 27001 information security management system. At the hardware level, a high-availability cluster was built using two Dell PowerEdge R740 servers equipped with Intel Xeon Gold 6348 processors, 256GB of DDR4 memory, and four 960GB SSD hard drives. This was paired with an EMC VNX5300 storage array for high-speed interconnection between the server and storage via a 10G fiber optic switch. The network security architecture used a Cisco ASA 5585-X firewall to physically isolate the DMZ from the intranet. Multi-layer access control lists based on source IP, destination port, and protocol type were configured, with URL filtering and application layer gateway functions enabled. The internal authentication system relied on OpenLDAP 2.5.13 to build a distributed directory service, which was synchronized bidirectionally with the company's Active Directory domain service via the LDAP v3 protocol. External access was only allowed through a Juniper SRX340 that supported the SSL / TLS 1.3 encryption protocol. The VPN gateway establishes a connection, and the VPN tunnel uses the AES-256-GCM encryption algorithm. The software operating environment is deployed on the CentOS 8.5 operating system, using Tomcat 9.0.78 as the Web container, MongoDB 4.4.24 to build a distributed document database, and the Angular12.2.10 framework to develop the front-end interactive interface. Company C applied for product registration for the "Medical Ultrasound Diagnostic Instrument", with a preset total period of 100 days, of which the registration submission sub-phase is from August 1 to August 20, 2025, a total of 20 working days, the review sub-phase is from August 21 to October 9, 2025, a total of 50 days, and the approval sub-phase is from October 10 to November 8, 2025, a total of 30 working days.
[0024] Registration Specialist A submitted his account identity information through a front-end form, including his username, a password encrypted with SHA-256 and a random salt, his affiliated organization for Company C, and the phone number of the person in charge, which was 10000000000. The system verified the business license and other qualification documents through OCR recognition, then called the blockchain smart contract to store the information and generate a user account. The administrator divided him into the "Registration Specialist" role through the permission configuration unit and assigned him the access and editing rights to the medical device registration application form template, technical document template, and test report template. On August 5, Registration Specialist A retrieved the "Medical Device Registration Application Form Template" with integrated data linkage function through the workflow engine. After editing, the system automatically verified the format and generated a PDF document with a timestamp. On August 15, the medical device review form returned by review expert B was received through the message queue. The review conclusion was "requires modification." The system automatically generated a modification task list containing opinions such as "supplement electromagnetic compatibility test report" and pushed it to Registration Specialist A's user account.
[0025] On July 20, 2025, the administrator uploaded the registration task through the WebGL visualization interface. The system automatically decomposed it into a sub-stage sequence of "registration submission → review → approval" based on the BPMN2.0 standard process framework, and assigned the registration submission sub-stage to the user account of registration specialist A. The Gantt chart was constructed through the D3.js data visualization framework, with the timeline as the horizontal axis and the sub-stage sequence as the vertical axis to display the progress. A green mark was displayed when the registration submission sub-stage was completed on August 21, and a yellow progress bar was displayed when the review sub-stage was started. If the review sub-stage was not completed on October 10, the corresponding node would be marked in red.
[0026] If audit expert E fails to complete the audit on October 8, one day before the audit deadline of October 9, the system will query his phone number through the LDAP directory service and connect to the operator's SMS gateway API to send a reminder SMS message containing a dynamic verification code. The content of the reminder SMS message is "[Medical Device Registration] Audit sub-stage has one day left, please complete the audit operation immediately". If it is still not completed at 18:00 on October 9, the system will query the phone number of the person in charge of his organization, call the PSTN telephone automatic dialing system, and use TTS speech synthesis technology to broadcast a timeout notification. The content of the notification is "The audit sub-stage has timed out and must be processed within 24 hours."
[0027] The "Medical Device Test Report Template" used by Registration Specialist A during the registration submission stage includes mandatory field verification, such as the test standard and test result fields. Submission is impossible if these fields are not filled out. The system uses the UUID v5 algorithm combined with a timestamp to generate a 128-bit task ID, creating "9A2B5C7D-1234-5678-90AB-CDEF12345678," and creates a three-level storage directory, "Root Directory / 9A2B5C7D / Registration Sub-Stage / Test Report.pdf." A mapping relationship is established from "Registration Sub-Stage to Medical Device Test Report" through the MongoDB embedded document structure, enabling document-associative storage.
[0028] When the administrator uploads a medical device registration task, the system executes a triple verification mechanism including format verification, compliance verification and integrity verification. The format verification check uses regular expressions to check the file extension and calls the Apache Tika 2.4.0 component to detect whether the file header matches the standard format of PDF or Word format. The compliance verification calls the NMPA regulatory library API to compare the list of necessary documents required by the "Medical Device Registration Management Measures". The integrity verification verifies whether the document signature column and directory page are complete. After approval on November 8, the administrator batch exports all registration process electronic documents according to the medical device task ID, including medical device registration application forms with electronic seals, medical device review forms with revision traces, medical device approval forms with anti-counterfeiting watermarks, etc., for regulatory reporting and internal archiving. It also supports management operations such as permission modification of the user account of registration specialist A.
[0029] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in this application should be included in the scope of protection of this application. Therefore, the scope of protection of this application should be based on the scope of protection of the claims.
Claims
1. A collaborative management system for the entire process of medical device registration based on local deployment, characterized by: Includes user interaction module, registration process management module, notification module and document management module; The user interaction module is used to register a user account and configure operation permissions for the registered user account. Based on the operation permissions of the user account, the user account performs process operations on the registration process sub-stages that match the operation permissions, and generates registration process electronic documents corresponding to the registration process sub-stages; The registration process management module is used to receive medical device registration tasks, break down the medical device registration tasks into a sequence of registration process sub-stages, and assign each registration process sub-stage in the sequence of registration process sub-stages to a user account with the required operation authority to wait for process operations; The notification module is used to preset time nodes for each registration process sub-stage and record in real time the deadline for the user account to complete the process operation of the registration process sub-stage that matches the operation authority. Based on the time nodes and deadlines, it performs hierarchical notification and warning, and displays the progress of the medical device registration task; The document management module is used to provide a registration process electronic document template corresponding to each registration process sub-stage in the registration process sub-stage sequence for process operations, and at the same time store the registration process electronic documents corresponding to the registration process sub-stage according to the medical device registration task.
2. According to claim 1, a local deployment-based collaborative management system for the entire process of medical device registration, characterized in that: The user interaction module includes a user registration unit, a permission configuration unit, an approval unit, an audit unit, an audit judgment unit and a registration submission unit; The user registration unit is used to obtain and verify the account identity information submitted by the user, including the user name, password, phone number, email address, role, affiliated organization and the phone number of the person in charge of the affiliated organization, and register the account identity information that has passed the verification to generate a user account; The authority configuration unit is used to divide user accounts into registration specialist accounts, review expert accounts and approval leader accounts based on the role authority control model. The registration specialist account is assigned the right to submit medical device registrations, the review expert account is assigned the right to review, and the approval leader account is assigned the right to approve; The registration submission unit is used to allow the registration specialist account to retrieve and edit the medical device registration application form template, medical device technical document template and medical device test report template, generate the medical device registration application form, medical device technical document and medical device test report, and at the same time, receive the medical device review form from the review unit; The review unit is used to allow the review expert account to review the medical device registration application form, medical device technical documents and medical device test report of the registration submission unit, and call the medical device review form template to edit the review opinions and review conclusions to generate the medical device review form, where the review conclusions include pass, fail and need to be modified; The review judgment unit is used to judge whether to submit the medical device review form to the approval unit for approval based on the record review conclusion in the medical device review form of the review unit; The approval unit is used to allow the approval leader account to review the medical device review form, call the medical device approval form template, edit the approval conclusion including approval or rejection, and generate the medical device approval form.
3. According to claim 2, a local deployment-based collaborative management system for the entire process of medical device registration, characterized in that: The approval unit is also used to call the medical device approval form template and synchronize the approval conclusion to the review unit and the registration submission unit so that the review expert account and the registration specialist account can view the approval result.
4. According to claim 1, a local deployment-based collaborative management system for the entire process of medical device registration, characterized in that: In the registration process management module, the process of breaking down the medical device registration task into a sequence of registration process sub-stages is as follows: Break down the medical device registration task into a sequence of registration process sub-stages through the preset standard process framework for medical device registration; The registration process sub-stage sequence is the registration submission sub-stage, the review sub-stage and the approval sub-stage.
5. According to claim 1, a local deployment-based collaborative management system for the entire process of medical device registration, characterized in that: In the notification module, the process of executing graded notification warning is as follows: If the deadline is 3 days or more before the time point, obtain the email address of the user account that has completed the process operation in the sub-stage of the registration process, and notify the user of the user account via email notification; If the deadline is less than 3 days and greater than or equal to 1 day before the time node, obtain the phone number of the user account that has completed the process operation in the registration process sub-stage and notify the user of the user account via phone text message; When the deadline is less than 1 day earlier than the time node, obtain the phone number of the person in charge of the institution to which the user account who completed the process operation of the registration process sub-stage belongs, and notify the person in charge of the institution to which the user account belongs by phone.
6. A locally deployed collaborative management system for the entire process of medical device registration according to claim 5, characterized in that: In the registration process management module, the process of displaying the progress of medical device registration tasks: The progress of the registration process sub-stage sequence of the medical device registration task is visualized in the form of a Gantt chart, and the registration process sub-stages in the registration process sub-stage sequence that have exceeded the time node and have not completed the process operation are marked in red.
7. According to claim 1, a local deployment-based collaborative management system for the entire process of medical device registration, characterized in that: The registration process electronic document template in the registration process management module is a structured document template, and the registration process electronic document template includes a medical device registration application form template, a medical device technical document template, a medical device test report template, a medical device review form template and a medical device approval form template.
8. According to claim 1, a local deployment-based collaborative management system for the entire process of medical device registration, characterized in that: In the document management module, the process of storing the electronic documents of the registration process corresponding to the sub-stages of the registration process according to the medical device registration task: Randomly assign a unique medical device registration task ID to each medical device registration task, and create an independent storage directory based on the medical device registration task ID, thereby associating and storing the electronic registration process documents corresponding to the sub-stages of the registration process; The electronic documents of the registration process include the medical device registration application form, medical device technical documents, medical device test report, medical device review form and medical device approval form.
9. According to claim 1, a local deployment-based collaborative management system for the entire process of medical device registration, characterized in that: In addition to the user interaction module, registration process management module, notification module and document management module, it also includes an administrator module for uploading medical device registration tasks to the registration process management module and exporting registration process electronic documents, and at the same time performing operations such as adding, deleting, modifying and checking user accounts.
10. A locally deployed collaborative management system for the entire process of medical device registration according to claim 9, characterized in that: The user interaction module, registration process management module, notification module, document management module and administrator module are all deployed on the company's internal server, and users need to access them through intranet authentication. Only encrypted VPN connections are allowed on the external network.