In early April, the American National Standards Institute (ANSI), together with the German Institute for Standardization (DIN), held a standards panel discussion that focused on medical device technology and included sessions covering standards and innovation, interoperability, and trade access.
More than 75 stakeholders representing German and U.S. industry and government attended the event in Washington, D.C. The event featured topical discussions on transatlantic trade and investment partnership, standards in the European Union and the United States, and standards in regulation, interoperability in the medical device sector, and risk management of 3D-printed medical devices.
The final session focused on innovative future topics, and covered biocompatibility and the 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.
Representative of German Industry and Trade, Dr. Thomas Zielke, was the guest speaker at the event.
ANSI president and CEO S. Joe Bhatia said the U.S. standardization community is truly committed to fostering global partnerships that lead to the greatest advancements for all stakeholders across borders and industry sectors.
“When all perspectives are present at the table, the most robust and effective standards and conformance solutions emerge,” Bhatia said. “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 final day of event, the National Institute of Standards and Technology (NIST) hosted the German delegation at its Gaithersburg, Maryland, campus. Attendees met with NIST staff to learn about the institute’s research activities that support innovations for medical devices, and also had the opportunity to tour several labs.
An in-depth prospectus on the one-day standards panel is being created by DIN and will be shared once available. Presentations from the standards panel discussions can be found here.
ANSI and DIN typically hold this collaborative initiative every two years in the Washington, D.C., area and have plans to meet bilaterally in late 2016 to discuss future workshops and topics.