Quality Management Principles (QMP)
This control contains details of the requirements for the Quality Management System (QMS) in place for AI/ML based SaMD.
This category supports the principles stated in section 5 of the IMDRF/SaMD N23.
Medical device QMS principles allow for scaling of activities depending on the type of medical device; risk of the product to patients; size of the organization; technology or automation used to manufacture; and other factors that are determined by the manufacturer to control quality and maintain the safe and effective performance of the medical device.
The manufacturing of SaMD, which is a software-only product, is primarily based on the development lifecycle activities often supported by the use of automated software development tools (build automation, use of source code management tools, etc.). These automated activities may in some cases replace discrete or deliberate activities (e.g., transfer of design to production) typically found in the manufacturing of hardware products. However, the principles in a QMS that provide structure and support to the lifecycle processes and activities are still applicable and important to control the quality of SaMD.
An effective QMS for SaMD should include the following principles:
An organizational structure that provides leadership, accountability, and governance with adequate resources to assure the safety, effectiveness, and performance of SaMD;
A set of SaMD lifecycle support processes that are scalable for the size of the organization and are applied consistently across all realization and use processes; and
A set of realization and use processes that are scalable for the type of SaMD2 and the size of the organization; and that takes into account important elements required for assuring the safety, effectiveness, and performance of SaMD (innermost circle in Figure 1).
In addition, the governance should include activities for systematically verifying the effectiveness of the established quality management system, such as undertaking QMS internal audits. Management review of the results of the QMS audits is a tool to ensure that the established QMS is suitable, adequate, and effective and that any necessary adjustments may be made as a result.
Similarly, according to the FDA AI/ML discussion paper:
The FDA expects every medical device manufacturer to have an established quality system that is geared towards developing, delivering, and maintaining high-quality products throughout the lifecycle that conforms to the appropriate standards and regulations. Similarly, for AI/ML-based SaMD, we expect that SaMD developers embrace the excellence principles of culture of quality and organizational excellence.
This compliance category supports the following controls/checks:
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