Medical Devices (includes In Vitro Diagnostics)
Strategic
Gert Bos, FRAPS
CTO, Executive Director & Partner at Qserve Group
Qserve Group Inc. - ENTERPRISE
Bassil Akra, M.Sc, PhD
Vice President
TUV SUD Product Service GmbH
Philippe Auclair, Pharma Dr, PhD , FRAPS
Senior Director Regulatory Strategy EMEA
Abbott - ENTERPRISE
Duncan McPherson, MBBS FRCA
Clinical Director of Devices
MHRA
Simon Richards, PhD
Vice President Divisional Regulatory Affairs
Abbott Rapid Diagnostics
Armin Ritzhaupt, PhD, MPH
Scientific Administrator
European Medicines Agency
Sue Spencer
IVD Lead/ Principal Consultant
Qserve Group EU
The basic requirements and massive changes from the revision of the European Medical Device Regulations is clear, but the system to assess compliance is just being build. But in this time of implementation one should get answers rather than more questions. This session will bring various stakeholders such as a regulatory lead from the European Authorities, a key voice on behalf on notified bodies, and an industry spokesman together in a panel steered by one of Europe's leading experts in the filed of implementing the EU MDR. The panel will address the most crucial topics that are hindering rapid implementation, and will look to provide as much clarity on these critical items as currently possible. It will help you understand how to solve the unsolvable, will instruct you and your implementation teams how to move on and what to aim for. The panel will tackle the key obstacles current on your way to implement the EU legislation, and will get you back on your way for a timely demonstration of your compliance to the new rules.