U.S.-German Standards Panel - Medizintechnik

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ANSI, American National Standards Institute, und DIN e. V. setzen ihre langjährige Zusammenarbeit als Partner der Transatlantic Market Conference und zuletzt des U.S.-German Standards Panels mit einer Konferenz fort, die sich auf Innovationen in der Medizintechnik fokussiert.  

Die Medizintechnik ist ein hoch innovativer Wirtschaftsbereich mit außerordentlichem Wachstumspotential. Normen helfen, diesen hochregulierten Markt zu erschließen und Inventionen als Produkte oder Dienstleistungen im Markt zu etablieren. Medizinprodukte sind zudem Gegenstand der Verhandlungen zum Freihandelsabkommen zwischen Europa und den USA.

Ziel ist es, mit Wirtschafts- und Regierungsvertretern über die gemeinsame Erarbeitung von Standards in innovativen Bereichen zu diskutieren und mögliche Chancen auszuloten. Eine frühzeitige Verständigung auf gemeinsame Standards in innovativen Gebieten kann dazu beitragen, die beiden Märkte zusammenzuführen und nachteilige Effekte durch unterschiedliche Rahmenbedingungen zu vermeiden. Darüber hinaus kann eine frühzeitige Verständigung auf wesentliche Standpunkte zwischen den transatlantischen Partnern die Überführung in globale Normen unterstützen.

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

Ihr Ansprechpartner

DIN e. V.

Sibylle Gabler

Am DIN-Platz
Burggrafenstraße 6
10787 Berlin

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