BIE6432   Introduction to Medical Device Regulation   (15 credits)

Description

Medical devices bring great benefit to patients, but it is essential to ensure that such devices are fit for purpose. This module explores the principles of regulation, and demonstrates how two of the world¿s largest regulatory frameworks (European and American) reduce risks and ultimately benefit the patient, the user and the manufacturer. You will simulate companies operating in this area, and learn the roles of Quality Standards, CE Marking, Notified Bodies, Competent Authorities and other key agencies. You will develop appreciation for the changing regulatory landscape, with special attention to the emerging use of computational modelling in this context.

Reading List