Vice President

TÜV SÜD Product Service

Dr. Akra is vice president at TÜV SÜD Product Service responsible for the global teams of active implantable, cardiovascular, orthopedic, aesthetic devices and clinical. He is involved in the development of different guidance documents, standards and regulatory documentation at the European and international level. Dr. Akra represents TEAM NB and NB MED in various task forces in Europe.

Senior Director, Regulatory Strategy and Advocacy

Abbott Quality and Regulatory

Philippe represents European Industry in various European Commission expert groups and is the proud recipient of a US FDA CDRH Director’s Special Citation for his engagement with GHTF. Since 2015, he serves as an advisor to the Asian Harmonization Working Party Technical Committee.

He chairs the Post Market Surveillance and the Notified Body Working Groups of association Medtech Europe.

Philippe received a “Global Leadership Award” from the Regulatory Affairs Professional Society (RAPS) in 2010, has been elected “RAPS Fellow” in 2012 and is a member of the RAPS European Advisory Committee.

Executive Director & Partner

Qserve Group

Gert is an expert in European regulations based on 15 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, and Head of notified body. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.

From his Ph.D. in biomaterial sciences, and postdocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession over the last 15 years he has been awarded as Fellow of RAPS.

Corp Quality Systems Manager, Global Steward Design Controls, Risk Management and Post Market Surveillance 

Boston Scientific

Kristen Hastings has over 20 years of experience in the medical device industry, including 15 years with Boston Scientific; the last four years have been in her current role, driving global processes.

Kristen began her career as a R&D engineer in blood filtration. She’s spent time working in startups, medical companies, design, and clinical research, and transitioned into quality when she joined BSC.

Her experience includes design controls, including new products and sustaining engineering; risk management, including post-market surveillance and cybersecurity risk; usability engineering; CAPA and program management; and implementation of standards and regulations.

Global Director, Product Development and Lifecycle Management

bioMérieux

Stephanie Lauman has over 17 years of experience in Medical and In Vitro Diagnostic Devices.  She is currently a Director, Global Quality responsible for Product Development and Lifecycle Management processes at bioMerieux.  Stephanie spent the first 11 years working in Research and Development responsible for Verification and Validation of new product development, Product Labeling, and Engineering.  She has spent the last 6 years at bioMerieux in the Quality organization including responsibilities for Design Controls, CAPA, Audits, Document Control, and Complaint Handling before transitioning into her current role.