Description
This course is a continuation of Medical Device Development. Topics cover the primary events that occur from just before "design freeze of a medical device up through clinical evaluation and commercial launch. Significant emphasis is placed on Quality Systems and Manufacturing, with attention to regulatory and legal compliance as well as design concepts. The course begins by supplementing already existing US Regulatory knowledge with the basics of medical device regulation in the EU, specifically the Medical Device Regulation (MDR) and In Vitro Devices Regulation (IVDR). This discussion then carries on to post-design activities, such as finishing construction of the Design History File and the first steps of commercialization. Once the device has entered to market, changes are often required to the manufacturing process and the device itself. Methods for enacting these changes and validating the resulting new processes are discussed. Finally the course ends with a deep discussion on post-market activities in relation to Product Management and clinical trials. The necessary regulations for running human studies are covered in detail, along with a description of the Product Manager's role in making the activities come together.
