Solutions from leading global experts for the EU MDR chaos

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

Wednesday, March 27, 2019, 8:30am-5:00pm EDT
Thursday, March 28, 2019, 8:30am-4:00pm EDT

Featured

Bassil Akra

Vice President

TÜV SÜD Product Service

Philippe Auclair, Pharmacist, Ph.D.

Senior Director, Regulatory Strategy and Advocacy

Abbott Quality and Regulatory

Gert Bos

Executive Director & Partner

Qserve Group

Kim Trautman

Executive Vice President, Medical Device International Services

NSF

Oliver Christ

Executive Vice President

PROSYSTEM, an NSF International Company

Kristen Hastings

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

Boston Scientific

Stephanie Lauman

Global Director, Product Development and Lifecycle Management

bioMérieux

““Are you on track? A typical MDR transition program takes 30 months. The EU transition window has 15 months left.”

”

— Gert Bos

Experts Bassil Akra (TÜV SÜD), Philippe Auclair (Abbott), Gert Bos (Qserve), Oliver Christ (PROSYSTEM, an NSF International Company), Kim Trautman (NSF), Kristen Hastings (Boston Scientific), and Stephanie Lauman (bioMérieux) 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. 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. Click here to view full agenda.

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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

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.

Philippe Auclair, Pharmacist, Ph.D.

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.

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.

Oliver Christ

Executive Vice President

PROSYSTEM, an NSF International Company

Oliver Christ has been active in international standardization efforts for more than 25 years and co-founded PROSYSTEM with the late Dr. Jürgen Stettin in 1999. The company was acquired by NSF International in 2017. In Germany, Mr. Christ has served as chair or co-chair of national committees including Human Factors/Usability for Medical Devices, Risk-Management for Medical Electrical Equipment, and Software for Medical Devices and Networked Medical Systems. Mr. Christ represents Germany on international standard committees for programmable electrical medical systems, human factors, risk management, software life cycle processes, and risk management for IT-networks incorporating medical devices (published as IEC 80001-1:2010). In 2013 Mr. Christ became an international delegate for Germany for the AAMI/UL initiative UL 2800 on Interoperability for Medical Devices. He received the DKE Needle award in 2014.

Kristen Hastings

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.

Featured

Stephanie Lauman

Global Director, Product Development and Lifecycle Management

bioMérieux

Featured

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 Wednesday, March 27, 2019, from 8:30am-5:00pm EDT - Thursday, March 28, 2019, from 8:30am-4:00pm EDT. 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.

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