In this presentation, we delve into the critical processes of verification and validation in MedTech product design. We look at what is required by ISO 13485 and the key standards of IEC 60601-1 and IEC 62304. We then explore the actual processes required for V&V for the overall system, electronics, software, and manufacturing processes. We delve into the practical details of registers, logs and review processes. The presentation is delivered by Geoff Sizer, CEO of Genesys Electronics Design and CTO of Genesys Medical Devices.
