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MDR

Is Your Testing Program Ready for the EU MDRs?

Is Your Testing Program Ready for the EU MDRs?

The new EU regulations will require much more documentation and perhaps some new evaluations from medical device manufacturers. An expert explains how to perform a gap analysis and begin preparing now for May 2020. The European Union’s new Medical Device...

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Why Labs Ask for so Much Info

Why Labs Ask for so Much Info

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 Jones, WuXi AppTec’s manager of package testing services,...

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Packaging Q and A

Packaging Q and A

ISO 11607 and MDR—impacts on your package testing and validation 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)....

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White Paper: Unknowns are Unacceptable™

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