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 ...
Intramuscular implantation assesses local tissue response to an implanted material for the ISO 10996-6 implantation test. However, manufacturers are on their own when it comes to how best to fulfill ...
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 ...
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 ...
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 ...
The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility issues medical device sponsors should consider in their premarket submissions. This is the second time the agency ...
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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