NAMSA

FDA EU MDR IVDR Clinical Evaluation Cybersecurity

NAMSA is a US-based medical device and IVD contract research organization providing regulatory consulting, testing, preclinical research and clinical services. Its consultants support FDA 510(k), De Novo, IDE and PMA strategies and submissions, quality systems and post-market compliance. NAMSA also advises on EU MDR and IVDR, clinical evaluation, biological safety, software as a medical device and cybersecurity documentation.

Learn more

What is a MDR UDI? Unraveling the Importance of Unique Device Identification

Anonymous

about 2 years ago

What is a UDI in the context of the MDR and FDA?

Accepted 1 answer

A Unique Device Identifier (UDI) is a distinctive code assigned to medical devices (and their packaging) to provide them with a unique identity. Simil

Performance Evaluation Report (IVDD)

Dr. Oliver Eidel

updated over 2 years ago

How to generate EUDAMED ID DI for MDD devices and what manufacturer device code is needed?

Anonymous · 1 comment

6 months ago

When registering MDD devices in EUDAMED using the EUDAMED ID DI, is a manufacturer device code required, and where can it be obtained? Does EUDAMED generate the EUDAMED ID and DI automatically, or doe

Accepted 7 answers

After ISO 13485 certification, you should close out any audit findings and address them in your Corrective and Preventive Actions (CAPA) process. Expe