Drafting Instructions for Use (IFUs) for medical devices is a delicate but critical task that supports patient safety. IFUs need to include detailed, action-oriented instructions on preparing, administering, handling, storing and disposing of the device. When...
The U.S. EPA banned the active ingredient in a popular disinfectant in 2018. Would you know what to do if your go-to cleaning product was phased out?
Regulations published by the International Standards Organization (ISO) provide a global structure for the medical device industry. These standards can affect development timelines for new products and, in some cases, can influence which products a company can keep on...
The current regulatory environment has created 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 manufacturers...
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...
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...
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...
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,...
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...
A risk-based approach that tailors test requirements to the specific risks of each device.
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
