The Medical Devices Introductory Course 2020

Resources at your disposal: Case Study Resources

 Your Team! Work as a team! (Please ensure everyone participates)

 Module Advisor / Presenter(s) – 1 Team Only (Sorry!) - non-specific assistance and general advice only

 Search for internet resources for each device  Product materials – if supplied

 Course materials [remember key references from presentation(s), for example...]: ● MDR 2017/745 – Annex VIII ● MDD 93/42/EEC – Annex IX ● GUIDANCE MEDDEV 2.4 / 1 Rev. 9 June 2010 ● GUIDANCE MEDDEV 2.1/3 rev.3 – Drug Device Borderline and Borderline Manual 1.22, 05/2019

The Organisation for Professionals in Regulatory Affairs

Selection of Medical Devices for Case Study ...

SOURCE: The Museum of Questionable Medical Devices Online; http://www.museumofquackery.com/welcome.htm