BIE6432   Regulatory Affairs for Medical Devices   (15 credits)

Description

The main objectives of this module are to familiarise students with; i. current regulatory frameworks for Medical Devices, ii. the system of risk classification and how this is applied within the wide range of Medical Devices currently available and the challenges presented by innovative solutions that may become available in the future, and iii. the role of Quality Standards, CE Marking, Notified Bodies, Competent Authorities and other key regulatory agencies in this process. The way in which the system of regulation is managed at national, European and in other areas of the world will be explored highlighting similarities and differences.

Reading List