Training Course on Good Management of Medical Devices including In Vitro Diagnostics and Companion D
|Event Date/Time: May 09, 2011||End Date/Time: May 12, 2011|
The course will give a clear guide how to develop practically a medical device. It will show how to identify the correct development path. For medical devices which need to be tested clinically, the process of planning, conducting and reporting a clinical investigation with medical devices will be explained to the course attendees. The practical differences between the development of pharmaceuticals and medical devices will be trained and the challenge of developing a drug device combination product should be sketched.
Responsibility in post marketing surveillance of medical devices (and drug devices combination products) according to the Medical Device Vigilance System will be explained and illustrated by examples. Differences between risk management of medical devices and pharmaceutical products will be pointed out.
Emphasis that 2007 47 comes into force in 2010.