This training course will provide you with a practical understanding of the EU regulatory requirements for medical device software. Once completed, you will have the skill and confidence to get your software product on the EU market. The course also examines areas such as clinical evaluations, investigations, post-market surveillance and risk management – specifically for software.

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 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

Module 3: Usability and Risk management for medical device software

• Safety risk management – ISO 14971
• Usability ISO 62366
• Apply risk management strategy for medical device software and create design inputs

Module 4: Development of medical device software

• Usability
• Operating environments
• Cyber security
• Maintenance
• Selection of toolchain
• ISO 62304, 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

Module 6: 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