Spinal system and contrast media injector firm Ulrich Medical said it has passed a certification audit in line with the upcoming European Medical Device Regulation (MDR).
The European Union has mandated that all class I medical devices meet standards set forth in the new MDR by 26 May 2020. Global auditing and certification firm TÜV Süd evaluated Ulrich Medical's processes and confirmed that they conform to the new MDR standards, the company said.
Ulrich Medical also passed an internal three-day review to meet Medical Device Single Audit Program (MDSAP) guidelines for medical devices distributed in the U.S., Japan, Canada, Australia, and Brazil.
