In this module the student will be introduced to the nuances of device approval within existing regulatory frameworks. Learners will use these frameworks to identify device attributes that must be scientifically proven before a device can be put on the market. Complex devices such as those with software (& AI) on board will also be examined. This module will enable learners to use the regulatory framework to their advantage in the design of devices and become versed in industry standard language and methods. Case study analysis will be a cornerstone of this module.
Overview of EU regulatory framework
Exploration of vertical and horizontal codes across MDR & IVDR
Bench testing, preclinical and clinical testing of devices
Evaluation of clinical evidence needed for devices
Software based devices, AI, cybersecurity overview
Case studies tackling bias, human factors and interface difficulties with devices
Case studies on recalls
Case studies on post market surveillance
