ARTICLE SUMMARY:
Cybersecurity, clinical evaluation procedures, and standards development were three active topics at the latest meeting of the International Medical Device Regulators Forum in Russia. CDRH international lead Melissa Torres provided an update at the recent AdvaMed MedTech Conference.
Global harmonization activity is picking up in the medical device community, and ground zero for the efforts is the International Medical Device Regulators Forum (IMDRF). The group’s management committee held its biannual meeting last month, September 16-19, in Yekaterinburg, Russia. Melissa Torres, the Center for Devices and Radiological Health’s (CDRH) Associate Director for International Affairs, updated a packed room at AdvaMed’s MedTech Conference September 25 on key outcomes from the meeting, including progress and new guidance.