Blog
The Secret Recipe for Testing Success
Every great chef has a secret “something” to their name – a recipe, a technique, an ingredient. It stands to reason that a lab largely concerned with...
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...
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 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.
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 effects on medtech manufacturers.
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)