Blog
A Guide to ISO 10993-18’s Analytical Evaluation Threshold
Identification standards are putting pressure on manufacturers’ submissions. Make sure your sensitivity is up to regulations. Medical Device Regulation (MDR)...
Enhancing Chemical Characterization with the CLAP Database
The Center for Devices and Radiological Health (CDRH) has spent years developing a standardized set of compounds to help analytical laboratories detect a...
2 Regulatory Standards That Ensure Medical Devices are Transported and Stored Safely
Medical devices need to reach patients in the most pristine condition to ensure safety and reduce the risk of unintended infection. Testing the integrity of...
Making the Most of the Evolving Q-Sub Program
When medical device manufacturers need to interact with U.S. regulatory agencies about the products they’re developing, they use the Q-Submission (Q-Sub)...
WuXi AppTec Experts on Regulators’ New Warning about Premarket Device Submissions
Earlier this year, U.S. regulators cautioned medical device manufacturers regarding the accuracy of data submitted by third-party testing laboratories. The...
WuXi AppTec Announces New Lab Manager at Munich Facility
WuXi AppTec is excited to announce the appointment of Dr. Thomas Halbritter as Director of Chemistry Operations at its new lab in Munich, Germany. Dr....
WuXi AppTec Opens New Lab in Munich to Offer Medical Device Testing Services
WuXi AppTec is opening a new lab in Germany that will bring out best in class extractables/leachables testing to Europe. The state-of-the-art facility will be...
Beyond Standard Testing: Exploring the Benefits of Custom Preclinical Solutions
In an increasingly complex world, one size rarely fits all. In most preclinical studies, testing services can be bought off-the-rack and fulfill all the needs...
What Manufacturers Need to Know About the MDR Deadline Extension
In March 2023, the European Parliament handed medical device manufacturers some breathing room when it amended the Medical Device Regulation (MDR) to allow...
Understanding ‘Assumed Release’ in ISO 10993-17:2023
The latest update to ISO 10993-17:2023 introduces significant changes to how medical device manufacturers and toxicologists can estimate and incorporate...
What Could a PFAS Phase-out Mean for Medical Product Manufacturers?
At the end of 2022, one of the world's largest manufacturers of PFAS (per- and polyfluoroalkyl substances) announced it would stop making the compounds and...
Navigating Cytotoxicity Failures in Medical Devices: Comprehensive Risk Management Strategies
Cytotoxicity testing is one of the standard biocompatibility tests for nearly all medical devices irrespective of their duration and nature of patient contact...