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Legal, Clinical & Regulatory

Clinical Data and CE Mark: What are We Doing Wrong?

A reader called saying companies are failing the clinical evaluation portion of the initial CE Mark or audit process and asked what insights could we offer now and at OMTEC? Here's our response.

Once an Easy Path, Europe’s Regulatory Approval Toughens

Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval.

FDA Update: Final Guidance on Medical Device Reporting

FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is to detect and correct device problems in a timely manner.