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...
Extraction Techniques: Designing the Right Studies to Get the Answers You Need
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...
What’s the Future of Biocompatibility?
A risk-based approach that tailors test requirements to the specific risks of each device.
6 MDR Facts to Not Lose Sight of
Despite the progress your company has made in preparing for the MDR, don’t overlook how these easy-to-miss factors affect your work.
Class Ir Extension Granted, but Don’t Slow Down
Despite the Class Ir MDR deadline extension, manufacturers must keep pace with compliance efforts to prepare for more potential, unpredictable turns.
Is Your Testing Program Ready for the EU MDRs?
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.
What you Need to Know About Reusable Devices and Europe’s MDR
Manufacturers of Class I reusable (Class Ir) medical devices need to identify data gaps and select the appropriate validation study to ensure their devices’ compliance with the European Commission’s Medical Device Regulation (MDR)
Preparing for MDR: Don’t Forget About Class I Reusable Devices
Class III medical devices are getting a lot of airtime in the discussion about the EU Medical Device Regulation (MDR) preparation, but we can’t forget about reusable devices.
Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1
When the Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) in 2020, requirements for medical devices in Europe will present greater regulatory hurdles.
Q&A: MedTech Industry Still Scrambling as MDR Deadline Nears
Advice on how medtech companies should approach their plan for regulatory testing.
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.