In an increasingly complex world, one size rarely fits all. In most preclinical studies, testing services can be bought off-the-rack and fulfill all the needs and desires of a device manufacturer or drug developer/sponsor. But sometimes, a custom fit is necessary....
In March 2023, the European Parliament handed medical device manufacturers some breathing room when it amended the Medical Device Regulation (MDR) to allow for a longer compliance period for certain medical devices and in vitro diagnostic devices. The move was...
At the end of 2022, one of the world's largest manufacturers of PFAS (per- and polyfluoroalkyl substances) announced it would stop making the compounds and discontinue using them across its entire product portfolio by the end of 2025. The company explained that PFAS...
As stated in the international packaging standard, ISO 11607, designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavor. Even if manufacturers opt for a proven packaging configuration, it needs to...
The medical device regulatory environment is continuously evolving. As regulatory body expectations become more demanding, manufacturers need to evaluate the safety implications of changes to their devices and processes. Manufacturing modifications are one example...
The current regulatory environment has created opportunities and setbacks for medical device companies as they work toward obtaining regulatory approval on their products. On the one hand, the delayed EU Medical Device Regulation (MDR) deadline means manufacturers...
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...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
