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 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...
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...
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...
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...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
