Modular quality management system and method

Abstract

A system for quality control of a medical device or software product, the system comprising a plurality of quality control (QC) modules, each QC module configured for one or more QC tasks of a QC process and configured for access by a plurality of users assigned roles and responsibilities for respective QC tasks, a quality control library configured to store a plurality of QC records comprising information associated with the QC tasks and government regulations or regulations applicable to respective QC modules and medical device products.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 611651, filed December 18, 2023, the entire contents of which are incorporated herein by reference. Background Technology

[0003] Many elements of the design, testing, manufacturing, and distribution of medical devices rely on effective quality control processes. Medical devices must provide safe and effective treatment and / or testing for patients and comply with numerous regulatory requirements. Many aspects, from design to distribution and post-market activities, must individually meet high-quality standards to satisfy these requirements. Manufacturers of these products frequently experience delays, interruptions, and / or non-compliance in meeting quality control requirements due to the complexity of the quality control processes and the lack of necessary coordination and / or planning, particularly for devices with many complex software and hardware components.

[0004] Controlling quality in many of these aspects will benefit from the coordination and overlap of quality control processes. Therefore, improved quality control methods and systems are needed for the effective, safe, and efficient design, manufacture, and distribution of medical devices. Summary of the Invention

[0005] The modular quality management system comprises quality system modules and a process library for quality control of medical diagnostic and therapeutic deliveries provided by medical devices, including instruments and / or software. The system is configured for users to manage module controls, library files, and tasks, including adding modules, assigning roles within modules to users, and defining responsibilities for quality system tasks associated with modules.

[0006] The modular quality management system comprises multiple modules, each serving as a distinct and corresponding library module for maintaining and controlling records related to diagnostic and therapeutic delivery. In some embodiments, this library includes a "Clinical Evidence and Research" module configured for QC tasks related to evaluating the quality of clinical evidence and research on the testing or use of a medical device. The module may store government regulations and ordinances (e.g., FDA regulations) related to the regulatory approval of the device, as well as records of clinical tests and studies used in connection with the approval process. One or more leaders and implementers of the module may be assigned to manage and implement QC for acquiring, storing, and evaluating the quality of device testing and clinical research materials. Enablers may be assigned to perform data analysis of clinical research and testing data.

[0007] Other modules may include: a management responsibility module, configured for the following QC tasks: assigning management roles and responsibilities within the system module to users; a system module, configured for the following QC tasks: training users and assigning tasks related to the management of quality control processes; an improvement and resolution management module, configured for the following QC tasks: tracking and improving the performance of QC tasks within the system module; a post-market module, configured for the following QC tasks: tracking issues associated with the medical device product after it has been placed in the hands of users; an information documentation module, configured for the following QC tasks: receiving and storing information related to the development and distribution of the medical device product; and a training module, configured for the following QC tasks: training users assigned roles within the quality control module.

[0008] The modules may include: an audit module configured for the following QC tasks: auditing the quality system tasks and records of multiple modules; a handling, storage, and distribution module configured for the following QC tasks: evaluating the handling, storage, and distribution processes of medical device products; and an validation and verification module configured for the following QC tasks: validating and verifying medical device products in accordance with specifications and / or regulations.

[0009] The modules may include: a procurement control module configured for the following QC tasks: tracking and evaluating requisitions for components of medical devices; a service and installation module configured for the following QC tasks: evaluating and ensuring globally consistent service and installation processes for users of the medical device; a change control module configured for the following QC tasks: tracking and evaluating changes to the design, manufacture, distribution, installation, and / or service provision of the medical device. Version and change information related to changes and applicability to specific specifications and / or regulatory rules or ordinances can be tracked. A clinical evidence and research module is configured for the following QC tasks: tracking and evaluating the quality of clinical evidence and studies on the testing or use of the medical device.

[0010] After initiating a modular quality management process for a product, modules can be generated in several waves to improve the system's efficiency and effectiveness. In some embodiments, modules related to system administration, training, and document control are generated in the first wave. Modules related to auditing, verification, change control, and procurement control are generated in the second wave. Modules related to design and development, infrastructure, commercialization, regulatory, and local requirements can be generated in the third wave.

[0011] A computer-implemented user interface is configured to manage the QC module library and implement quality system processes. This interface is configured for users to manage module controls, library files, and tasks, including adding modules, assigning roles within modules, and defining responsibilities for quality system tasks associated with those modules.

[0012] In some embodiments, module records relating to quality system tasks (e.g., procedures or processes) are constructed with fields according to a template that provides an increasing level of detail related to the task. Administrative users or implementers are assigned to perform specific tasks or roles. In some embodiments, task assignment and / or reminders may be triggered or dynamically generated based on a specific timeline and / or the creation and / or (partial) completion of other tasks. Attached Figure Description

[0013] Detailed explanation is provided with reference to the accompanying drawings.

[0014] Figure 1A is a diagram illustrating the modules generated in a modular quality management system (mQMS) according to some embodiments.

[0015] Figure 1B is a diagram illustrating the structure of the recorded mQMS library according to some embodiments.

[0016] Figure 2 is an illustrative diagram of a user interface for operating a modular quality management system according to some embodiments.

[0017] Figure 3 is an illustrative flowchart of a process for implementing a modular quality management system according to some embodiments.

[0018] Figure 4 is an illustrative template interface, according to some embodiments, for representing and displaying information about quality management processes or tasks in a modular quality management system.

[0019] Figure 5 is an exemplary representation of a library record in a modular quality management system according to some embodiments.

[0020] Figure 6 illustrates a computer system in a modular quality management system according to some embodiments. Detailed Implementation

[0021] A system and computer-implemented process for controlling and improving the quality of medical device products are described. In some embodiments, the modular quality management system is configured with multiple modules for performing quality system tasks, such as the design, manufacture, and distribution of medical device products and software. Each module is configured to manage tasks associated with the quality system processes, which may include assisting in compliance with regulatory rules or laws, testing products to meet specific requirements specifications, ensuring component consistency and quality, product training and use, and minimizing risks in development and production. Each module may be associated with a user of the system, including implementers or managers of tasks, coordination between modules, and / or supervision / management of tasks, and / or other users. In some embodiments, the enabler of a module may be delegated tasks such as performing data analysis and / or risk governance to achieve task completion (e.g., evaluating clinical research data / performance).

[0022] The system may include a database of records containing information related to modules, tasks, and users. The user interface is configured to allow users to access, view, and modify information / records, including adding or removing modules, assigning roles / tasks to users for modules, and adding / modifying information associated with quality management tasks. In some embodiments, tasks may be assigned and notified to users of the system, which may be triggered within the system based on the status of other tasks. Information stored in the records may include, for example, national or local regulations, design documents, specifications, component procurement documents, and test protocols and results.

[0023] Figure 1A is a diagram illustrating the modules generated in waves within a modular quality management system according to some embodiments. The modular quality management system allows selected waves of system modules to be generated and initially configured sequentially during the quality management process. As further described herein, each module can be configured to manage a specific quality management task. The use of waves and the order in which modules are created contribute to optimizing the overall efficiency and performance of the quality management system. The first wave 100 typically targets modules for management, training, and documentation roles and tasks. The second wave is used to establish modules for performing core quality management tasks, including auditing, validation and verification, procurement and change control, and clinical research, etc. The third wave of modules is configured to manage product-specific tasks and documentation, including infrastructure, design, and regulatory requirements, etc.

[0024] In the first wave 100, the modules for establishing management tasks and roles include a management system module 102, which is configured to establish a scalability management structure for implementing quality control over medical device / software products. This structure may include modules that will be generated within the system, as well as the delegation of general tasks and roles for quality system management of these modules. A management responsibility module 104 is configured to assign management responsibility roles and tasks within the system (including under other modules). An improvement and resolution management module 106 is configured to assign management responsibility roles and tasks for improving management operations. A training module 108 is configured to manage training operations related to the use of the quality control management system and products, and to perform tasks within the quality control management system.

[0025] Post-marketing module 110 is configured to assign roles and tasks for monitoring and improving product quality after commercialization or launch and during patient use. Module 112 for controlling documented information is configured to manage the creation, storage, and security of stored documents or records related to quality management processes. Such documents may include design specifications, test protocols, test results, regulatory requirements, and other records to be stored in the quality management system repository, as further described herein.

[0026] The second wave of modules 120 for certain key quality management processes includes module 122, which is configured to audit product development, manufacturing, and distribution processes to ensure compliance with quality control. The handling and storage module 124 is configured to ensure quality in product handling, storage, and distribution. The validation and verification module 126 is configured to manage processes for validating and validating products. The change control module 128 is configured to identify and track changes or proposed changes made in the design, manufacturing, and / or distribution of products. The procurement control module 130 is configured to identify and track the procurement of product components. The clinical evidence and research module 132 is configured to identify and track clinical testing of the product. The service and installation module 134 is configured to identify and control the installation and service delivery processes for the product.

[0027] The modules of the third wave 140 target specific key processes in the design, manufacturing, testing, and distribution of the product. The third wave 140 includes an infrastructure and equipment control module 142 configured to identify and manage the infrastructure (e.g., factory) and manufacturing equipment used to manufacture the product. A design and development module 144 is configured to identify and manage product design and development processes and documentation. In some embodiments, the modules of the third wave are generated in connection with establishing and initiating quality system tasks (e.g., management / audit) and retaining / generating documentation (e.g., applicable regulations, market research) that can be used to ensure quality and compliance in the design, manufacturing, and marketing / distribution of the product.

[0028] Commercialization module 146 is configured to identify and manage commercialization processes for the product (e.g., marketing / advertising). Production and process control module 148 is configured to identify and manage procedures for the production of the product. Regulatory module 150 is configured to identify and manage regulatory processes for approving / certifying the product in accordance with government regulations, and digital control module 152 is configured to identify and manage digital content associated with product tracking of digital components of the medical device, including, for example, compliance with regulations governing the security of personally identifiable information and data. Additional local requirements module 154 is configured to identify and manage regulatory compliance at the local or regional level (e.g., state and municipal).

[0029] Figure 1B is a diagram illustrating the structure of a modular quality management system library of records according to some embodiments. The library 160 of records may include records 180 for product specifications and design, test documents, audit and post-market data, where copies and version information of these records are stored / managed in an electronic database and storage platform (e.g., the cloud). An appendix 170 of quality-related records is also stored within the library and may include, for example, applicable regulations (e.g., FDA), certifications (e.g., FDA approval), definition appendices defining product-specific and its development / production / testing terminology, and control records (e.g., managers / implementers / enablers and associated responsibilities and modules).

[0030] Library 160 may further include a web-based quality manual detailing the processes for creating / configuring a modular quality management system for a medical device / software product (e.g., creating modules for each wave, configuring modules, assigning tasks, and triggering tasks). This manual may also include the structure of the modular quality management system established for a specific product, including its corresponding modules and information about each module, applicable tasks, and users / roles. In some embodiments, a graphical user interface allows computer access to and management of the libraries and records stored therein (e.g., as shown in Figure 2).

[0031] Figure 2 is an illustrative diagram of a user interface 200 for operating a modular quality management system according to some embodiments. The user interface 200 is configured to allow the user to select from multiple modules 210 (e.g., as described with reference to Figure 1A), where the current user is identified at 212, the currently selected module at 214, and the appointed manager-user at 216. A selectable table 220 displays quality management tasks 224 associated with modules and / or active users, and a status 226 associated with each task. A selectable library menu 230 is also displayed and provided for browsing, viewing, and adding / removing records within the modular quality management library.

[0032] Tasks associated with a module may include, for example, audits pending completion under that module, where a status can indicate, for example, whether the audit has been completed or what stage the task is at. Selecting a task may prompt the display of further information about the task, such as, for example, identifying the user assigned to complete or manage the task, the task's progress, documents / records associated with the task (e.g., audit records), and the deadline for completing the task. For example, selecting a task may cause the library menu 230 to display or highlight library records associated with the currently selected task (e.g., required specification documents, regulatory requirements).

[0033] The browsable library record interface 230 provides a folder / archive view of records / files within the modular quality management system. This interface gives users access to records in the library, including the ability to view, add, remove, and modify records at 225. As further described herein, these records / files may include: audit records 235, design, testing, and manufacturing records; and appendices 240, which include regulations, guidelines, organizational charts, user roles, and assignment, definition, and quality management system manuals.

[0034] The records that make them accessible and displayed can be provided in response to and associated with a module selected from module 210, and / or based on security privileges assigned to users / accounts identified by the quality management system. Tasks can be assigned to specific users (e.g., implementers / enablers). Tasks can be configured to alert users to the actions required for a task and can be configured with triggers to create or assign tasks in response to an activity in the system (e.g., completing a task, failing to complete a task on time, or failing to meet specific quality requirements while performing a task).

[0035] The configuration tool can be accessed via selection input 215, from which modules can be further configured. Additional configuration changes may include configuring notifications to users regarding open tasks and configuring task triggers. Access to certain configuration features may be based on user / account security authentication. Users may have privileged access and responsibilities to specific modules and / or between modules, where they are assigned responsibility for the implementation or management of corresponding tasks within the module.

[0036] Figure 3 is an illustrative flowchart of a process for implementing a modular quality management system according to some embodiments. At 310, the process for developing a medical device / software product has begun. At 320, quality management modules for the product, such as those further described herein, are created using the modular quality management system. In some embodiments, modules are created in several waves (such as referring to Figure 1A). At 330, creating modules includes assigning users / roles / tasks to modules, including, for example, assigning owners / leaders or managers tasks to assume management roles for modules and systems. For example, a system management module includes tasks for constructing a quality management system for the product, including general processes and scheduling for the system, and determining additional modules that should be included for quality management of the product.

[0037] At 340, assign an implementation role (or implementer) to the module. Implementers can be assigned tasks such as acquiring and reviewing documents as a function, for example, auditing. At 350, assign enablers to the module. Enablers can be assigned tasks that include risk assessment and data analysis for one or more modules, including evaluating consistency in meeting / maintaining product design or manufacturing requirements associated with the corresponding module. Enablers can be delegated to review clinical trial data to determine the quality of the data and, based on that data, associate efficacy and / or risk with the use of the product. The cycle of creating modules continues from box 320 until all modules or a wave of modules is created at 360.

[0038] At point 370, obtain the documents / records used for the quality management module and tasks. These documents / records may include, for example, product design and manufacturing documents, test documents, and copies or links to applicable regulations.

[0039] At point 380, quality management tasks related to product design, modification, and / or testing are performed. These tasks may have already been assigned to specific users (e.g., implementers, enablers) within the quality management system and modules at point 340. In some embodiments, the system is configured to monitor the status of these tasks (e.g., completion, quality incident / failure) and store information about the status in the system's module library records. As the design, production, testing, and distribution evolve or are modified, tasks can be repeated at point 360, and new records can be created accordingly.

[0040] In some embodiments, identifying a task as completed can trigger the assignment of other module tasks or their states as requiring completion. For example, once testing of a software product is completed in the validation and verification module, the system can assign or trigger an open-source audit for implementers to complete or supervise under the audit module. The task can then be identified in the user interface (e.g., interface 200 in Figure 2) of the user who assigned the task.

[0041] At 385, quality management tasks related to the production, distribution, and support of the product are performed. Similar to the tasks performed at box 380, these tasks can be assigned (and / or triggered) to specific users within the quality management system and modules. Such tasks can be assigned within, for example, handling, storage, and distribution modules or service and installation modules. At 390, given the system's quality management operations, the product can be modified and improved if necessary. Documentation for these improvements / modifications is obtained at 370, and the quality management process can continue until the production and / or use of the product ceases.

[0042] Figure 4 is an illustrative template interface, according to some embodiments, for representing and displaying information for quality management processes or tasks within a modular quality management system. Template 400 provides a framework for storing / displaying information or documents representing tasks or processes within the modular quality management system. Detailed view selection 420 is used to select what information to provide in the interface. Document information field 405 can provide document file name, version information, document title, and other information about the document. Reminder field 425 displays reminders relative to the process, such as, for example, the due date for completing a module task.

[0043] In some embodiments, the information displayed in the document is organized such that the level of detail increases from left to right. Overview column 430 provides a general type or name of the task or process activity. Description and Explanation column 460 provides further details about the corresponding task / process activity. Column 460 may include a clear description of the user (e.g., implementer / enabler) performing the quality management task or activity, such as how an audit or data analysis is conducted. Additional Information cell 470 provides additional information about the quality management process, such as the expected time to complete the process and its current progress / status. Required Personnel cell 475 provides a list of users assigned to complete the process / task / activity.

[0044] The process trigger field 440 identifies what other activities (e.g., task / process completion) trigger the current process or task. The process result field 450 identifies the goal or expected result of completing the process / task, and may identify what additional tasks / processes are triggered by the completion of the current process / task. In some embodiments, this interface allows certain users (e.g., managers / controllers) to edit process files, including modifying the user assignments at process trigger 440, expected result 450, description 460, additional information 470, and / or 475.

[0045] Figure 5 is an exemplary representation of a library record in a modular quality management system according to some embodiments. The record represents a specific government regulation relating to a corresponding module of the quality management system (e.g., modules 134, 152, and 154 of Figure 4). Associated quality management system tasks may include review by the relevant implementer / enabler to obtain and / or review documents used to verify compliance with the relevant regulation (e.g., for digital controls, device installation).

[0046] Any computer system mentioned herein, such as one used to host a system and implement processes for describing the management of liver diseases, can utilize any suitable number of subsystems. An example of such a subsystem is shown in computer system 10 of Figure 6. In some embodiments, the computer system includes a single computer device, wherein the subsystem may be a component of the computer device. In other embodiments, the computer system may include multiple computer devices, each being a subsystem with internal components. The computer system may include desktop and portable computers, tablets, mobile phones, and other mobile devices. In some embodiments, cloud infrastructure (e.g., Amazon Web Services), graphics processing units (GPUs), etc., may be used to implement the disclosed technologies.

[0047] The subsystems shown in Figure 6 are interconnected via system bus 75. Additional subsystems, such as printer 74, keyboard 78, storage device 79, monitor 76 (which is connected to display adapter 82), etc., are shown. Peripheral devices and input / output (I / O) devices connected to I / O controller 71 can be connected to the computer system via any number of components known in the art, such as input / output (I / O) port 77 (e.g., USB, FireWire®). For example, I / O port 77 or external interface 81 (e.g., Ethernet, Wi-Fi, etc.) can be used to connect computer system 10 to a wide area network, such as the Internet, a mouse input device, or a scanner. The interconnection via system bus 75 allows central processing unit 73 to communicate with each subsystem and control the execution of multiple instructions from system memory 72 or storage device 79 (e.g., a fixed disk, such as a hard disk drive, or optical disk), as well as the exchange of information between subsystems. System memory 72 and / or storage device 79 may contain computer-readable media. Another subsystem is the data collection device 85, such as a camera, microphone, accelerometer, etc. Any data mentioned herein can be output from one component to another and can be output to the user.

[0048] A computer system may include multiple identical components or subsystems, connected together, for example, via an external interface 81 or an internal interface. In some embodiments, the computer system, subsystem, or device may communicate via a network. In this case, one computer may be considered a client and another computer may be considered a server, with each computer being considered part of the same computer system. The client and server may each include multiple systems, subsystems, or components.

[0049] Various aspects of the embodiments may be implemented in a modular or integrated manner using hardware (e.g., application-specific integrated circuits or field-programmable gate arrays) and / or computer software having a generally programmable processor, in the form of control logic. As used herein, processors include single-core processors, multi-core processors on the same integrated chip, or multiple processing units on a single circuit board or networked. Based on the disclosure and teachings provided herein, those skilled in the art will know and understand other ways and / or methods of implementing the embodiments of the present invention using hardware and combinations of hardware and software.

[0050] Any suitable computer language, such as Java, C, C++, C#, Objective-C, Swift, or scripting languages, such as Perl or Python, can be used, employing, for example, conventional or object-oriented techniques, to implement any software component or function described in this application as software code executable by a processor. The software code can be stored as a series of instructions or commands on a computer-readable medium for storage and / or transmission. Suitable non-transitory computer-readable media may include random access memory (RAM), read-only memory (ROM), magnetic media (such as hard disk drives or floppy disks), or optical media (such as optical discs (CDs) or DVDs (Digital Universal Disk), flash memory, etc.). The computer-readable medium can be any combination of such storage or transmission means.

[0051] Such programs can also be encoded and transmitted using carrier signals adapted for transmission over wired, optical, and / or wireless networks conforming to various protocols, including the Internet. Thus, computer-readable media can be created using data signals encoded with such programs. Computer-readable media encoded with program code can be packaged with compatible devices or provided separately from other devices (e.g., for download via the Internet). Any such computer-readable media can reside on or within a single computer product (e.g., a hard drive, CD, or an entire computer system) and can exist on or within different computer products within a system or network. The computer system may include monitors, printers, or other suitable displays for providing the user with any of the results mentioned herein.

[0052] Any method described herein can be performed wholly or partially by a computer system including one or more processors, which can be configured to perform the steps. Therefore, embodiments may relate to a computer system configured to perform the steps of any method described herein, possibly having different components performing the respective steps or groups of steps. Although the steps are presented as numbered, the steps of the methods herein may be performed simultaneously or in different orders. Furthermore, some steps may be used in conjunction with some steps from other methods. Additionally, all or some steps may be optional. Moreover, any step of any method may be performed using modules, units, circuits, or other components for performing those steps.

[0053] The specific details of a particular embodiment may be combined in any suitable manner without departing from the spirit and scope of the embodiments of the present invention. However, other embodiments of the invention may be directed to specific embodiments relating to each individual aspect, or specific combinations of these individual aspects.

[0054] For purposes of illustration and description, exemplary embodiments of the invention have been described above. It is not intended to exhaustively describe the invention or limit it to the precise forms described, and many modifications and variations are possible in accordance with the above teachings.

[0055] Unless otherwise specified, references to “a,” “an,” or “the” are intended to mean “one or more.” Unless otherwise specified, the use of “or” is intended to mean “includes or,” not “excludes or.” Referring to a “first” component does not necessarily require the provision of a second component. Furthermore, unless explicitly stated otherwise, references to “first” or “second” components do not limit the referenced component to a specific location.

[0056] All patents, patent applications, publications, and specifications mentioned herein are incorporated herein by reference in their entirety for all purposes. None of them are considered prior art.

Claims

1. A system for quality control of medical devices or software products, the system comprising: a) An electronic quality control library comprising multiple quality control (QC) modules, each QC module being configured for one or more QC tasks in a QC process and being configured to be accessed by multiple users assigned roles and responsibilities for the corresponding QC tasks; the quality control library being configured to store multiple QC records including information associated with the QC tasks and government regulations or ordinances applicable to the corresponding QC modules and medical device products; b) One or more processors, said one or more processors being programmed and configured to: c) Provide a user interface configured to manage a library of QC modules and implement quality control processes, wherein the management and implementation include: adding or removing modules; assigning roles within the modules to users and responsibilities for quality control tasks associated with the modules; and adding, removing, or modifying QC records for the corresponding modules.

2. The system of claim 1, wherein the plurality of quality control modules comprises two or more of the following: a) Management responsibility module, which is configured for the following QC task: assigning management roles and responsibilities within the system module to users; b) A management system module configured for the following QC tasks: training users and assigning tasks for the management of quality control processes; c) An improvement and resolution management module, configured for the following QC task: tracking and improving the performance of the QC task of the management system module; d) Post-market module, which is configured for the following QC task: tracking issues associated with the medical device product after it has been delivered to users of the product; e) An information documentation module configured for the following QC tasks: acquiring and storing information related to the development and distribution of the medical device product; and f) Training module, which is configured for the following QC task: training users who have been assigned roles within the quality control module.

3. The system of claim 1, wherein the plurality of quality control modules comprises two or more of the following: a) An audit module, which is configured to perform the following QC task: audit the quality control tasks and records of the plurality of modules; b) A handling, storage, and distribution module configured for the following QC task: evaluating the handling, storage, and distribution processes for medical products; c) Validation and verification module, which is configured for the following QC task: to validate and verify the medical device product in accordance with specifications and / or regulations; d) Procurement control module, which is configured for the following QC task: tracking and evaluating requisitions for components of medical devices; e) Service and installation module, which is configured for the following QC task: evaluating the process of providing service and installation for users of medical devices; f) A change control module configured for the following QC tasks: tracking and evaluating changes in the design, manufacture, installation, and / or service provision of medical devices; g) Clinical evidence and research module, which is configured for the following QC task: tracking and evaluating the quality of clinical evidence and research on the testing or use of a medical device.

4. The system of claim 1, wherein the one or more processors and the user interface are further configured to: The user of the interface and library is assigned and managed a governance role and an implementation role, wherein the governance role is assigned privileged module and / or inter-module access permissions and responsibilities for the corresponding module, and the implementation role is assigned module access permissions and implementation responsibilities for the corresponding tasks within the module.

5. The system of claim 1, wherein the one or more processors and the user interface are further configured to: Enabler roles are assigned and managed for each of the modules, wherein the enabler roles are assigned to data analysis and risk governance tasks for the corresponding module to assess the consistency of fulfillment / maintenance of product design or production requirements associated with the corresponding module.

6. The system of claim 1, wherein the QC records for the regulatory module and the post-market module among the plurality of modules include clinical or testing data and regulations for the approval or certification of the medical device in accordance with government regulations.

7. The system of claim 1, wherein the QC record for the local requirements module includes clinical or testing data and regulations for the approval or certification of the medical device in accordance with local or regional government regulations.

8. The system of claim 1, wherein the QC record for the change control module includes: Changes or proposed changes to the design, manufacture, and / or distribution of the medical device product; And tracking of version information regarding the changes and their applicability to specific regulatory rules or regulations.

9. The system of claim 1, wherein the QC record for the digital control module includes: Test data and tracking of the digital components of the medical device are used for compliance with regulations governing the security of personally identifiable information and data.

10. The system of claim 1, wherein the QC records for the service and installation modules include data and tracking of globally uniform service and installation processes.

11. The system of claim 1, wherein the interface configured to manage the QC module library is configured to execute a process of generating modules in multiple waves, the first wave including modules associated with system management, training, and document control.

12. The system of claim 11, wherein the plurality of wavelets comprises: The second wave of modules is associated with auditing, verification, change control, and procurement control; And a third wave of modules related to design and development, infrastructure, commercialization, regulatory requirements, and local requirements.

13. The system of claim 1, wherein the interface is configured to provide QC task details arranged with fields of progressively increasing detail.

14. The system of claim 1, wherein the interface is configured to dynamically generate records and / or user notifications for new tasks based on a specific timeline and / or the creation and / or partial completion of other QC tasks.

15. A computer-implemented method for controlling the quality of a medical device or software product, the method comprising: a) Generate a quality control library for records of the quality control management system; b) Generate and configure multiple quality control (QC) modules for managing quality control processes, wherein the configuration includes: c) Assign quality control tasks to be performed on the quality control process for each module; d) Assign QC roles and responsibilities for the quality control tasks to multiple users of the QC module; e) Assigning records from the library to the QC module, the records including information associated with the QC task and government regulations or ordinances applicable to the respective QC module and medical device or software product; f) Generate a user interface configured to manage the QC modules and library records, wherein the management and implementation include: adding or removing modules; assigning roles within the modules to users and responsibilities for quality control tasks associated with the modules; and adding, removing, or modifying the quality control library records for the corresponding modules.

16. The method of claim 15, wherein the plurality of quality control modules comprises two or more of the following: a) Management responsibility module, which is configured for the following QC task: assigning management roles and responsibilities within the system module to users; b) A management system module configured for the following QC tasks: training users and assigning tasks for the management of quality control processes; c) An improvement and resolution management module, configured for the following QC task: tracking and improving the performance of the QC task of the management system module; d) Post-market module, which is configured for the following QC task: tracking issues associated with the medical device product after it has been delivered to users of the product; e) An information document module configured for the following QC tasks: receiving and storing information related to the development and distribution of medical device products; and f) Training module, which is configured for the following QC task: training users who have been assigned roles within the quality control module.

17. The method of claim 15, wherein the plurality of quality control modules comprises two or more of the following: a) An audit module, which is configured to perform the following QC task: audit the quality control tasks and records of the plurality of modules; b) A handling, storage, and distribution module configured for the following QC task: evaluating the handling, storage, and distribution processes for medical products; c) Validation and verification module, which is configured for the following QC task: validating and verifying medical device products in accordance with specifications and / or regulations; d) Procurement control module, which is configured for the following QC task: tracking and evaluating requisitions for components of medical devices; e) Service and installation module, which is configured for the following QC task: evaluating the process of providing service and installation for users of medical devices; f) A change control module configured for the following QC tasks: tracking and evaluating changes in the design, manufacture, installation, and / or service provision of medical devices; g) Clinical evidence and research module, which is configured for the following QC task: tracking and evaluating the quality of clinical evidence and research on the testing or use of a medical device.

18. The method of claim 15, further comprising: The user of the interface and library is assigned and managed a governance role and an implementation role, wherein the governance role is assigned privileged module and / or inter-module access permissions and responsibilities for the corresponding module, and the implementation role is assigned module access permissions and implementation responsibilities for the corresponding tasks within the module.

19. The method of claim 15, further comprising: Enabler roles are assigned and managed for one or more of the modules, wherein the enabler roles are assigned to data analysis and risk governance tasks for the corresponding modules to assess the consistency of fulfillment / maintenance of product design or production requirements associated with the corresponding modules.

20. The method of claim 15, wherein the QC records for the regulatory module and the post-market module among the plurality of modules include clinical or testing data and regulations for the approval or certification of the medical device in accordance with government regulations.

21. The method of claim 15, wherein the QC record for the local requirements module includes clinical or testing data and regulations for the approval or certification of the medical device in accordance with local or regional government regulations.

22. The method of claim 15, wherein the QC record for the change control module includes: Changes or proposed changes to the design, manufacture, and / or distribution of medical device products; And tracking of version information regarding the changes and their applicability to specific regulatory rules or regulations.

23. The method of claim 15, wherein the QC record for the digital control module comprises: Test data and tracking of digital components of medical devices or software are used for compliance with regulations governing the security of personally identifiable information and data.

24. The method of claim 15, wherein the QC records for the service and installation modules include data and tracking of globally uniform service and installation processes.

25. The method of claim 15, further comprising: The modules are generated in multiple waves, with the first wave including modules related to system administration, training, and document control.

26. The method of claim 25, wherein the plurality of wavelets comprises: The second wave of modules is associated with auditing, verification, change control, and procurement control; And a third wave of modules related to design and development, infrastructure, commercialization, regulatory requirements, and local requirements.

27. The method of claim 15, wherein the interface is configured to provide QC task details in fields arranged in a progressively increasing manner of detail.

28. The method of claim 15, wherein the interface is configured to dynamically generate records and / or user notifications for new tasks based on a specific timeline and / or the creation and / or (partial) completion of other QC tasks.

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