The Medical Devices Introductory Course 2020

Beyond CE Marking

Medical Device Introductory Course

10 July 2020

Jonathan Hughes, Ph.D., FTOPRA. JHRA Ltd jhughesra@icloud.com +44 1494 727101

The Organisation for Professionals in Regulatory Affairs

“ Beyond CE Marking ”

To Infinity and

In this presentation we will cover • Medical Device Regulation – US – Japan – Rest of the World • Global Harmonisation – IMDRF [GHTF], AHWP – GMDN – MDSAP / RPS • A word about the future