The sudden closure of a medical device sterilization plant in February and a second plant closure planned for later this year have raised questions about the effects on medtech manufacturers.
From 26th May 2020 MDR will come in to effect in EU Member States. This regulation will apply to all manufacturers who are selling medical devices within Europe. How EU MDR affects medical device manufacturers With recent updates to ISO 10993-1 and the MDR on track to...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.