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U.S.-German Standards Panel - Medical Technology

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DIN and ANSI, the American National Standards Institute, continue to work closely together as partners of the Transatlantic Market Conference and the U.S.-German Standards Panel - the 2016 Panel topic is "Innovation in the medical device sector".

The medical technology sector is very innovative and has an extremely high growth potential. Standards help inventions become established as new products or services on this highly regulated market. Medical devices are also a subject of the Transatlantic Trade & Investment Partnership (TTIP) negotiations between Europe and the USA.

The aim is to bring representatives of industry and the state together to explore opportunities for the joint development of standards in innovative areas. Agreeing upon common standards at an early stage can help bring together these two markets, thus reducing the adverse effects of differing regulatory frameworks. Coming to an understanding on key issues early on can also facilitate the adoption of common standards at a global level.

9:00

Welcome address

Joe Bhatia, President and CEO, American National Standards Institute (ANSI)

Welcome address

Rüdiger Marquardt, Member of the Executive Board, DIN

9:15

Keynote Speech

Recent developments in electronic medical records – Implications for standardization and public policy

Tim Büthe, Associate Professor of Political Science and Public Policy, Duke University

9:45

The Transatlantic Trade and Investment Partnership (TTIP)

Moderator: Sibylle Gabler, Senior Manager Government Relations, DIN

 

TBT Chapter and Annex on Medical devices

Isabel Pastor Arenillas, Trade Counselor, EU Delegation to the USA

 

U.S. perspective

Ashley Miller, Director, Industrial Goods Market Access (TTIP sectors), USTR

10:30

Coffee Break

10:45

Standards in the EU and US – A tool for meeting global requirements

Moderator: Gordon Gillerman, Director, Standards Coordination Office, NIST, US DoC

 

Harmonized Standards (EU)

Matthias Marzinko, Director International Standards Management, Drägerwerk  AG & Co. KGaA

 

Recognized Standards (US)

Scott Colburn, Director, Standards, US FDA

 

Conformity Assessment – Keys to Multiple Market Access

Dr. Royth von Hahn, Global Director Functional Safety and Software, Medical and Health Services, TUV SUD Product Service Division

 

What Global Companies are Doing

Elisabeth George, Vice President of Global Government Affairs, Standards & Regulations, Philips Healthcare, USA

 

Brief Panel Discussion

12:05

Standards in Regulation - Use cases

 

Current issues - disposable medical products

Herrmann Riesenberger, Head of Working Group Standardization, BVMed, The German Medical Technology Association

 

Electromedical devices

Pamela Gwynn, Principal Engineer for Medical and Home Healthcare Equipment, Underwriters Laboratories (UL)

 

Standards and Medical Imaging

Diane Wurzburger, Executive, Regulatory Affairs, GE Healthcare/MITA

 

Brief Panel Discussion

12:50

Lunch

13:45

Interoperability in the medical device sector

Moderator: Hermann Behrens, Head of department Innovation, DIN

 

Internet of Medical Systems and IT Services

Prof. Dr. J.-Uwe Meyer, CEO, CTO, MT2IT GmbH & Co. KG

 

Implementing Information Exchange Standards in Healthcare Facilities

Dezso Csipo, President, Object Forge, Inc.

 

Interchange formats of medical documents – IT-specifications

Dr. Georg Heidenreich, Manager Healthcare IT Standards, Siemens Healthcare GmbH

 

Safety and Security Standards for Medical Application Platforms

John Hatcliff, University Distinguished Professor, Department of Computing and Information Science, Kansas State University

 

Medical Robots

Mike Yramategui, Fellow Regulatory Engineer, Intuitive Surgical, USA

15:25

Coffee Break

15:45

Innovative future topics

Moderator: Carol Herman, Senior Vice President, Standards & Policy Programs, AAMI

 

Safe and dynamic networking in operating room and hospital

Björn Andersen, Research Assistant, University of Lübeck Institute of Medical    Informatics

 

Risk management of 3D printed medical devices

Roderick McMillan, Materials Development Manager, DePuy Synthes

 

Biocompatibility and evolution of risk management in safety evaluation of medical devices

Jon Cammack, Global Vice President of R&D/Clinical Quality, AstraZeneca

 

Innovation and Adaptation in the Development of Standards for Absorbable Implants

Byron Hayes, Biomaterials Research and Development, W.L. Gore & Associates, Inc.

 

Standardization in the field of regenerative medicine

Prof. Dr. Michael Doser, Deputy director, Head of development in Biomedical   Engineering, Institute of Textile Technology and Process Engineering

17:05

Panel Discussion on innovative future topics

  • Prof. Dr. J.-Uwe Meyer, CEO, CTO, MT2IT GmbH & Co. KG
  • Dr. Georg Heidenreich, Manager Healthcare IT Standards, Siemens Healthcare GmbH
  • Jon Cammack, Global Vice President of R&D/Clinical Quality, AstraZeneca
  • Byron Hayes, Biomaterials Research and Development, W.L. Gore & Associates, Inc

17:45

Closing remarks

 

Rüdiger Marquardt and Joe Bhatia

Contact

DIN e. V.
Sibylle Gabler

Am DIN-Platz
Burggrafenstraße 6
10787 Berlin

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