News

International Standards Conference Coming in March

In March, more than 150 representatives and consultants—from medical device companies, the U.S. Food and Drug Administration (FDA), and other organizations—will gather in Herndon, VA for the 23rd Annual AAMI/FDA International Conference on Medical Device Standards and Regulation.

The 2013 conference, to be held March 20-21, will bring attendees insights from the FDA on the latest activities within the Center for Devices and Radiological Health (CDRH) and how they will impact the medical device industry, including an update on the 510(k) process, the FDA’s new Innovation Pathways initiative, which seeks to help bring safe, breakthrough medical products to patients in a timely manner, and more. 

Participants will also learn how the recent changes to the European Medical Device Directive will impact the international marketplace.

Joe Bhatia, president and CEO of the American National Standards Institute (ANSI) will share his insights on China and the growing importance of the global standards market.

These topics, along with others on medical device security considerations, interoperability challenges, and an update on the activities of the International Medical Device Regulators Forum (IMDRF)—which has taken the place of the Global Harmonization Task Force (GHTF)— will be covered during the conference. 

Posted: December 11, 2012