Manufacturers are not the only ones facing challenges due to the updates to ISO 10993 and other recent regulatory changes. The evolving standards are also affecting testing labs. Previous industry projected timelines and costs are becoming less feasible with today's...
Regulatory
Responding to Regulatory Requests for Additional Information
There's been a significant increase in the prevalence of requests for additional information in recent months, particularly following ISO 10993-18:2020. Collaborating on these responses is the best way to deliver quality answers promptly, and WuXi AppTec Medical...
Webinar: Biocompatibility Evaluation of Medical Devices for Global Registration
When preparing your medical device for a global submission, there are many factors to consider from developing a testing plan to keeping up with regulatory standards and much more. While it can be daunting to move forward with a global submission, there are resources...
AATCC TM 100-2019: Assessment of & What It Means for Medical Textiles
Staying up to date on regulatory requirements and industry standards can be a challenge with ever-evolving expectations. However, keeping a close eye on changes in standards will insure that your medical device testing stays on track to a successful submission. Today,...
A Guide to ISO 10993-18’s Analytical Evaluation Threshold
New identification standards are putting pressure on manufacturers' submissions. Make sure your sensitivity is up to regulations. Medical Device Regulation (MDR) and recent International Organization for Standardization (ISO) revisions emphasize the importance...
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)
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.