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...
Medical devices need to reach patients in the most pristine condition to ensure safety and reduce the risk of unintended infection. Testing the integrity of medical device packaging is a crucial step in ensuring devices are transported and stored without being...
When medical device manufacturers need to interact with U.S. regulatory agencies about the products they’re developing, they use the Q-Submission (Q-Sub) program. The program allows manufacturers to engage in collaborative discussions with regulators that can shape...
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 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....
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...
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 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...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
