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

Session 1

2 November 2022 | 120 mins | 10am UK

Module 1: Software overview and definitions

• Is your software a device?
• Examine the definitions and intended use
• Review the regulations

Module 2: Bringing medical device software to market

Examine the regulatory requirements to put a medical device software on the market.

• Examine the Medical Device Regulation (MDR) and FDA systems
• Engaging with a Notified Body
• Controlling software suppliers and subcontractors
• Software traceability
• App stores and digital distribution platforms
• Software recalls

Session 2

2 November 2022 | 120 mins | 1pm UK

Module 3: Usability and Risk management for medical device software

• Safety risk management – ISO 14971
• Usability ISO62366
• Applying an effective risk management strategy for medical device software
• Design inputs

Module 4: Development of medical device software

• Usability
• Operating environments
• Cyber security
• Maintenance
• Selection of tool chain
• ISO62304, a practical approach
• SAMD and embedded software
• Document structure

Module 5: Maintenance strategies

• Platforms and keeping up to date
• Udi maintenance
• Configuration management
• What are significant changes

Post market considerations and regulatory maintenance

• Post-market regulatory requirements
• Implementation of Post Market Clinical Follow-up for medical device software
• Successfully bringing together risk management, clinical evaluation and PMS to streamline ways of working

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.