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Package Design

Packaging Q and A

Packaging Q and A

ISO 11607 and MDR—package testing and validation impacts Medical device manufacturers around the world are working to ensure their package designs are in line with the recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR). Britt...

White Paper: Unknowns are Unacceptable™

Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.