REC Webcast - EU MDR: Experience gained from post-market surveillance and reporting

Speakers

Philippe Auclair, Senior Director, Regulatory Strategy and Advocacy, Abbott Quality and Regulatory
Philippe joined Abbott in 1994. He represents European Industry in various European Commission expert groups and actively participates as trainer in programs organized by Regulatory Authorities around the world. Since 2015 he is an Industry advisor to the Asian Harmonization Working Party Technical Committee. He is Chairman or co-chair of the Post Market Surveillance, the Notified Body, the International Regulatory and the clinical Working Groups of the European medical device manufacturers’ trade association Medtech Europe. He is a member of the European Advisory Committee and of the board nominating committee of the Regulatory Affairs Professional Society (RAPS). Philippe received the “Global Leadership Award” from RAPS in 2010, has been elected “RAPS Fellow” in 2012. Philippe is also the proud recipient of an FDA CDRH Director’s “Special Citation” for his work at Global Harmonization Task Force.


Markus Poettker, PMS EU MDR Workstream Lead, Smith&Nephew
Markus is a member of the EU MDR Project team at Smith&Nephew leading the Post Market Surveillance work stream. In this role, he is responsible that the requirements of the EU MDR are correctly interpreted and implemented across the company. Prior to this, he spent seven years in Quality & Regulatory roles, at last he was the Director of Complaint Management and Head of Regulatory Compliance with global responsibility for Complaint Handling, Medical Device Reporting and interaction with Regulatory Agencies. Markus is co-chair of MedTech Europe PMS & Vigilance Working Group and a member of the corresponding standard committee to ISO TC 210 at the Swiss Association for Standardization. Markus holds a master’s degree in law from WWU Münster, Germany.