The current regulatory environment has created both opportunities and setbacks for medical device companies as they work toward obtaining regulatory approval on their products. On the one hand, the delayed EU Medical Device Regulation (MDR) deadline means that...
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.
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)
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.
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.