Biocompatibility testing is a necessary part of any medical device validation process. It is governed by FDA’s ISO 10993 guidance document, a seemingly rigid statement that provides a general matrix ...
Good Laboratory Practices for In Vivo and In Vitro Testing. If a company is willing to spend large amounts of time and money on biocompatibility testing, it should go the extra mile and ensure that ...
In addition to the in vivo rat micronucleus test, STEMart offers a comprehensive range of biocompatibility, microbiology, and sterility testing services. These complete solutions for medical device ...
Dublin, Dec. 15, 2025 (GLOBE NEWSWIRE) -- The "Biocompatibility Testing Market - Global Forecast 2025-2032" report has been added to ResearchAndMarkets.com's offering. Senior executives in healthcare ...
The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that may not be biocompatible for use in ...
Several months after the US Food and Drug Administration (FDA) announced the first wave of testing laboratories accredited under its accreditation scheme for conformity assessment (ASCA) pilot, the ...
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Mastering risk management for safer medical devices
From concept to clinical use, medical device safety depends on proactive risk management. Tools like FMEA help teams identify and prioritize potential failures before they cause harm. Combined with ...
STEMart announces the expansion of its genetic toxicology capabilities with the In Vivo Rat Micronucleus Test services. NEW YORK, NY, UNITED STATES, January 26, 2026 ...
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