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Microbial Identifications: Managing Bioburden Monitoring Results

Explore bioburden monitoring techniques for medical devices and how to choose the right microbial identification method with NAMSA’s expert guidance.

A Product Development Plan For My Laboratory Developed Test

Discover key strategies for LDTs facing FDA regulation changes in our latest blog on product development planning.

Navigating Medical Device Clinical Trial Site Selection: A Data-Driven Approach

Learn how to align clinical evaluations with MDR in our guide, featuring NAMSA’s expert insights and auditor feedback for medical device manufacturers.

Best Practices for MDR-Compliant Clinical Evaluations

Learn how to align clinical evaluations with MDR in our guide, featuring NAMSA’s expert insights and auditor feedback for medical device manufacturers.

Navigating the New MDCG Guidance Documents on CIP and IB

Discover key insights on the latest MDCG guidance for EU medical device clinical investigations, aiding in compliant CIP and IB development.