Course Outline

Course Information

• The course begins at the time stated at the top of the page
• The course is broken up into modules outlined below
• There will be breaks between modules

3 February 2026 | 7 July 2026

1-Day Live Online Training
Register at the top of the page.

Session 1

120 mins | 10:00 AM UK

Introduction to AI in Medical Devices

• Definitions and scope: AI, ML, Deep Learning in medical devices
• Real-world examples: diagnostics, decision support, monitoring systems
• Regulatory perspectives: how AI differs from traditional SaMD

Designing AI for Compliance

• Good Machine Learning Practice (GMLP) – principles for trustworthy design
• Data considerations: training sets, bias, transparency, traceability
• Explainability and human oversight in AI-enabled systems

Regulatory Frameworks & Classifications

• MDR/IVDR rules and their impact on AI-based devices
• FDA categorisation of AI/ML-enabled devices
• Global perspectives: IMDRF guidance, MHRA position papers

Session 2

120 mins | 10:00 AM UK

Evolving Regulatory Changes & Developments

• EU AI Act: scope, risk classification, and interaction with MDR/IVDR
• FDA guidance on AI/ML features – Action Plan and Predetermined Change Control Plans (PCCPs)
• Emerging global trends in AI governance

Standards & Best Practices

• Overview of relevant IEC/ISO standards in development (e.g., IEC 62304 updates, IEC TR 60601-1 guidance for AI, ISO/IEC JTC1 work on AI)
• Role of standards in demonstrating safety, performance, and compliance

Lifecycle, Submissions & Post-Market Considerations

• Strategies for clinical/performance evaluation of AI-enabled devices
• Managing updates in continuously learning systems
• Post-market surveillance, monitoring, and regulator expectations

Wrap-Up and Case Studies

• Examples of AI-based devices successfully regulated in EU and US
• Lessons learned and regulatory outlook
• Interactive Q&A

Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.

Richard has worked on many software related projects for clients helping them achieve regulatory compliance in the EU. In addition, he has delivered both online and classroom training courses on medical device software. He can provide multiple examples and case studies during training, drawing on his extensive industry experience.