Medical Device Platform Blog
Stay up to date with our most recent news and updates
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.
What’s the Future of Biocompatibility?
A risk-based approach that tailors test requirements to the specific risks of each device.
Streamlining Submissions with Product Adoption for Radiation Sterilization
Product adoption for radiation sterilization can cut costs and save time today and in the future.
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.
WuXi AppTec Medical Device Testing Doubles Chemistry Capacity to Counteract MDR Pressures
To accommodate the high demand and help manufacturers meet the May 26, 2021 deadline, WuXi Medical Device Testing recently expanded its chemistry lab in Minnesota.
Stop Letting GLP Stunt Your Chemistry Studies
The FDA’s Good Laboratory Practice (GLP) regulations have led to some misconceptions for medical device manufacturers (MDMs). To better understand the misconceptions about when to apply GLP testing, I think it’s important to first look at what the FDA GLPs actually say:
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.
Response to COVID-19: We’re Here For You
As the world faces challenging times, we remain true to our promise to serve and support our customers. We are here to help. Getting lifesaving devices to...
Is Your Testing Program Ready for the EU MDRs?
The new EU regulations will require much more documentation and perhaps some new evaluations from medical device manufacturers. An expert explains how to...
How Should Medtech Manufacturers Cope With Sterilization Plant Closures?
The sudden closure of a medical device sterilization plant in February and a second plant closure planned for later this year have raised questions about the...
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’...
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...