Identification standards are putting pressure on manufacturers’ submissions. Make sure your sensitivity is up to regulations. Medical Device Regulation (MDR) and International Organization for Standardization (ISO) revisions emphasize the importance of chemical...
The Center for Devices and Radiological Health (CDRH) has spent years developing a standardized set of compounds to help analytical laboratories detect a broad spectrum of chemicals. The Chemicals List for Analytical Performance (CLAP) database provides a benchmark...
Earlier this year, U.S. regulators cautioned medical device manufacturers regarding the accuracy of data submitted by third-party testing laboratories. The regulators brought attention to concerning reports of falsified and unreliable data from some labs, many of...
WuXi AppTec is excited to announce the appointment of Dr. Thomas Halbritter as Director of Chemistry Operations at its new lab in Munich, Germany. Dr. Halbritter will lead the extractable/leachables team at the new facility, which is scheduled to open in Q4...
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...
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...
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...
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...
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...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
