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...
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...
High-resolution quadrupole time-of-flight (QTOF) gas chromatography–mass spectrometry (GC-QTOF-MS) provides a powerful combination of high mass accuracy with trace level detection capabilities. Applying the technique to extractables and leachables testing (E&L)...
As regulatory guidance evolves, a new expectation around preclinical medical device safety testing is emerging: Unknown chemicals are unacceptable. The new risk-based approach means regulatory bodies expect complete chemical characterization. Testing can include all...
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,...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
