ANSI - American National Standards Institute
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ANSI and DIN Standards Panel Focuses on Medical Device Technology and Transatlantic Cooperation

Sessions Cover Standards and Innovation, Interoperability, and Trade Access

05/16/2016

The American National Standards Institute (ANSI), together with the German Institute for Standardization (DIN), held a standards panel discussion focusing on medical device technology on April 12 in Washington, DC.

Over 75 stakeholders representing German and U.S. industry and government attended the event, which featured topical discussions on “Transatlantic Trade and Investment Partnership (TTIP),” “Standards in the EU and U.S. and Standards in Regulation,” “Interoperability in the Medical Device Sector,” and “Risk Management of 3D-Printed Medical Devices.” The final session, “Innovative Future Topics,” covered biocompatibility and evolution of risk management in safety evaluation of medical devices, innovation and adaptation in the development of standards for absorbable implants, and standardization in the field of regenerative medicine.

ANSI president and CEO S. Joe Bhatia opened the discussions, noting how ANSI has had a collaborative dialogue with the European Standards Organizations (ESOs) — CEN, CENELEC, and ETSI — for over 20 years, and that these relationships have resulted in an open dialogue which has evolved to include the European Commission in recent years. Dr. Thomas Zielke, representative of German Industry and Trade (RGIT), was the guest speaker at the event.

“The U.S. standardization community is truly committed to fostering the global partnerships that lead to the greatest advancements for all stakeholders across borders and industry sectors,“ Mr. Bhatia said. “When all perspectives are present at the table, the most robust and effective standards and conformance solutions emerge. Harmonized standardization between the U.S., the EU, and Germany will benefit the transatlantic market as well as global trade. Our international collaboration can foster comprehensive solutions to address some of the technological, economic, and societal challenges that we all face.”

On the last day of event on April 13, the National Institute of Standards and Technology (NIST) hosted the German delegation at NIST’s Gaithersburg, MD, campus. Attendees met with relevant NIST staff to learn about the institute’s research activities that support innovations for medical devices and had an opportunity to tour several of the NIST labs.

A more in-depth prospectus regarding the one-day standards panel is being created by DIN and will be shared when complete. Presentations from the April 12 standards panel discussions can be found here.

ANSI and DIN typically hold this collaborative initiative every two years in the D.C. area and have plans to meet bilaterally in late 2016 to discuss future workshops and topics.

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