Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...
Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
As data-driven innovation profoundly changes every industry, the healthcare sector is also affected. Digital twins – virtual copies of physical devices – are essentially changing the ...
Industry standards group AIM Global has released the latest version of its standard for the testing of non-implantable wireless medical devices, to help users and manufacturers better determine if ...
According to OECD Test Guideline 474, the in vivo rat micronucleus test detects the presence of micronuclei in erythrocytes with retained chromosomal fragments or intact chromosomes. STEMart now ...
Agencies in Malaysia and Thailand have implemented a regulatory reliance program for medical devices after a successful three ...
WuXi AppTec is parting ways with its U.S. medical device testing business, selling its two stateside locations to the Ohio-based regulatory consulting firm NAMSA. The deal includes facilities in ...
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