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...
In cases where biocompatibility testing may not entirely mitigate medical device risk, chemical characterization data has become increasingly important. The updates to ISO 10993-18:2020 are applying pressure to supply sufficient chemistry data, meaning the industry...
Having a clear understanding of the chemistry required for regulatory submission is not an easy feat. Chemistry background knowledge is crucial when making decisions regarding study design and preparing a device for submission. With this insight, you can gain more...
A risk-based approach that tailors test requirements to the specific risks of each device.
Despite the progress your company has made in preparing for the MDR, don’t overlook how these easy-to-miss factors affect your work.
Despite the Class Ir MDR deadline extension, manufacturers must keep pace with compliance efforts to prepare for more potential, unpredictable turns.
The European Union’s new Medical Device Regulations (EU MDR) will require that all medical devices – even legacy products – have updated clinical data and technical documentation to support device safety and conformity with the new regulatory standards.
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
