[FEATURED] Whole EU Medtech Industry Behind Latest Push To Have MDR Problems Tackled at Highest Levels
Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go […]
[FEATURED] EU Notified Body MDR/IVDR Certificates Data: A Slow-Motion Car Crash
Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go […]
[FEATURED] More Flexible Approach Proposed For EU Notified Body Technical Documentation Reviews
Shortfalls in manufacturer technical documentation submitted to notified bodies cause delays for manufacturers and notified bodies alike. A new document from the notified body association, TEAM-NB, aims to streamline processes.