This course offers a comprehensive overview of Quality Management System (QMS) considerations essential for the development and regulatory approval of diagnostic AI models classified as medical devices. It is specifically tailored for AI models requiring premarket clearance by the U.S. FDA, EU MDR, and other regulatory bodies that mandate adherence to ISO 13485 standards. The training focuses on detection AI testing, excluding large language models (LLMs), and guides participants through key QMS aspects outlined in an organization's Quality Manual, emphasizing its critical role in shaping company-wide expectations and processes.

The course systematically explores ISO 13485 requirements, highlighting best practices and essential considerations for relevant clauses. Participants will gain insights into the scope of the QMS, design controls—including Product Requirements Specifications (PRS), System Requirements Specifications (SRS), Software Design Specifications (SDS), Risk Management Process, and Verification & Validation (V&V) testing—and the creation of technical files necessary for EU and U.S. market clearances. Additionally, the training addresses cybersecurity documentation, post market surveillance, and the nuances of design changes, manufacturing processes, labeling, complaints handling, and vigilance reporting.

Further, the course delves into regulatory references, offering guidance on documents such as AAMI 34971, FDA Good Machine Learning Practices, FDA Clinical Decision Support Software Guidance, and more, providing a robust framework for navigating the regulatory landscape of diagnostic AI models.

Through this training, participants will acquire the knowledge needed to manage the QMS for AI models effectively, ensuring compliance with regulatory requirements and facilitating successful product development and market entry.

Over the course of two (2) hours, the attendee/participant will:

• Analyze their own QMS for any gaps & process improvement ideas for their AI/ML enabled medical devices.
• Apply regulatory requirements for their AI/ML-enabled medical devices.
• Understand the importance of clearly defining and documenting the ‘medical device’ vs. ‘other non-device software functions’ within a software app in their QMS.

Medical Device Manufacturing professional in the Quality, Regulatory, AI/ML Engineering, Clinical and Statistics departments