Solutions from leading global experts for the EU MDR chaos

Join us for this advanced workshop AT CINTAS CENTER, XAVIER UNIVERSITY, Cincinnati, Ohio:

  • Thursday, November 21, 2019, 8:30am-5:00pm EST

  • Friday, November 22, 2019, 8:30am-4:00pm EST

Experts Bassil Akra (TÜV SÜD), Gert Bos (Qserve), Kim Trautman (NSF), Stephanie Lauman (bioMérieux), and Lindsay Taylor (Abbott) will lead you through the development of a time-critical action plan for keeping your medical devices on the EU market using proven strategies and tactics.

Featured
Bassil Akra
Bassil Akra

Vice President, Strategic Business Development, Global Medical Health Services (MHS)

TÜV SÜD Product Service

Gert Bos
Gert Bos

Executive Director & Partner

Qserve Group

Kim Trautman 
Kim Trautman 

Executive Vice President, Medical Device International Services

NSF

Stephanie Lauman
Stephanie Lauman

Global Director, Product Development and Lifecycle Management

bioMérieux

Lindsay Taylor
Lindsay Taylor

Director, Regulatory Affairs

Abbott

At this workshop, you will develop:

  • Advanced strategies to effectively work with notified bodies.

  • Insightful game plans for compiling the data required to certify your products.

  • Recommendation plans to heighten awareness of the urgency to take action and gain support from senior leaders (CEO, COO, CQO, CFO, Chief Legal Officer, etc.).

Walk away with practical solutions to successfully prepare your company for the fast-approaching regulation deadline of May 26, 2020.


You Have Questions, and Time is of the Essence!

  • Will you need to spend millions to fulfill clinical data requirements on well-established technologies or legacy devices?

  • What do you need to do if your Notified Body has lost/limited designation?

  • How do you manage the increased cost of hiring, training and development of new resources?

  • How do you communicate with the EU Commission if the Eudamed database is not ready?

  • What are best practices for connecting postmarket surveillance to design changes under the new legislation?

Expert Leaders

Featured
Bassil Akra
Bassil Akra

Vice President, Strategic Business Development, Global Medical Health Services (MHS)

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.

Gert Bos
Gert Bos

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.

Featured
Stephanie Lauman
Stephanie Lauman

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.  

Featured
Lindsay Taylor
Lindsay Taylor

Director, Regulatory Affairs

Abbott

Kim Trautman
Kim Trautman

Executive Vice President, Medical Device International Services

NSF International

Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She is focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program.

Ms. Trautman was previously Associate Director for International Affairs in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs, and led continuing harmonization efforts with ISO 13485.

Logistics

The EU MDR Workshop will be Thursday, November 21, 2019, 8:30am-5:00pm EST - Friday, November 22, 2019, 8:30am-4:00pm EST. Arrive at 8:00am and enjoy a complimentary warm breakfast before the workshop starts. For complete information on planning your trip to the workshop, click here.