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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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White Paper: Unknowns are Unacceptable™

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