Essentials of European Medical Device Regulatory Affairs - October 2019
October 2019
Essentials of European Medical Device Regulatory Affairs
Janis Bayley
Eli Lilly and Company
Jane Arnold-Round NAMSA
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
Agenda • Housekeeping
• What is a Device? • Who’s who – Key Stakeholders • Legislation • Classification of Devices • Conformity Assessment • Device Labelling • Clinical Evaluations • Post Market Requirements
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