“CLINICAL DATA FOR SAFETY AND PERFORMANCE OF MEDICAL DEVICES (MD) TO OBTAIN MARKET AUTHORIZATION APPROVAL”

Chair:

Ghazaleh Gouya, Priv. Doz Dr. med Cardiologist, Founder of Gouya insights, GPMed Board Member & IFAPP Board Member

Speakers:

‘Design of clinical MD investigations and approvable endpoints’

Andreas Beust, Dr, Chief Scientific Officer, GCP-Service International Ltd. & Co. KG

‘How much clinical data from Medical Device studies is enough for CE mark?’

Shayesteh Fürst-Ladani, MBA, MSc, GFMD, Senior Vice President SFL, Head of SFL Group

‘Guidance documents’

Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, School of Medicine, Trinity College Dublin

Speakers