WuXi AppTec is opening a new lab in Germany that will bring out best in class extractables/leachables testing to Europe. The state-of-the-art facility will be located in the Bavarian capital of Munich and will expand our ability to meet the demands of the medical...
General
What Manufacturers Need to Know About the MDR Deadline Extension
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...
Understanding ‘Assumed Release’ in ISO 10993-17:2023
The latest update to ISO 10993-17:2023 introduces significant changes to how medical device manufacturers and toxicologists can estimate and incorporate constituent release into the toxicological risk assessment (TRA) process. We explore the concept of release...
What Could a PFAS Phase-out Mean for Medical Product Manufacturers?
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...
Navigating Cytotoxicity Failures in Medical Devices: Comprehensive Risk Management Strategies
Cytotoxicity testing is one of the standard biocompatibility tests for nearly all medical devices irrespective of their duration and nature of patient contact per ISO 10993-1:2018 and the U.S. FDA's Guidance on the Use of ISO 10993-1 (2020). Although cytotoxicity...
Beyond UV: Harnessing LC-MS for Comprehensive Medical Device Chemical Characterization
As the world of medical technology progresses, so does the landscape of regulatory expectations. Gone are the days when unknown chemicals would be allowed or accepted in preclinical testing. For today's regulatory bodies, ambiguity in chemical characterization is no...
Medical Device Packaging Validation: 5 Testing Best Practices for 2023
Medical device packaging validation helps ensure that a medical device cleared for commercialization will arrive to the end-user in an uncompromised, sterile state, and non-sterile product remains uncompromised during its journey to the user. Here are five important...
How ISO 10993-17:2023’s Toxicological Screening Limit Can Change the Game for Medical Device Manufacturers
Medical device developers are constantly looking for regulatory changes that may impact how they work. Sometimes minor changes in regulation can make their lives a lot easier, while alterations add extra steps to a process elsewhere. Changes to ISO 10993-17 have been...
How the Updated ISO 10993-17:2023 Could Change Toxicological Risk Assessment
When it comes to medical devices, regulatory standards are never set in stone. The guidance offered by authorities is ever evolving, as technology advances, new data becomes available and old interpretations become obsolete. As medical device manufacturers innovate,...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
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