Validation of medical devices, a process of confirming that the medical device or software works in the way in which it was intended, is a fundamental part of the medical device manufacturing cycle. Validation guarantees safety, ensures effectiveness and proves that medical devices meet predefined requirements such as functional specifications, regulatory requirements and user needs. We are delighted to welcome two speakers, Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, and Tautvydas Karitonas, Managing Director of the UK company Test Labs, to discuss aspects of validation of medical devices.
This webinar, being run by MDMC, will include discussion of design verification and validation for medical device development within an ISO 13485:2016 framework which will highlight the difference between verification and validation as well as the importance of planning verification and validation activities throughout the entire design cycle. Case studies which will highlight common issues will also be presented.
