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 ...
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 ...
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 ...
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 ...
Cellulose dermal filler achieves critical biocompatibility milestones, paving the way for clinical trials OTTAWA, ON, April 29, 2025 /PRNewswire/ - Spiderwort Biotechnologies Inc., a pioneering ...
Many medical procedures could benefit from the use of tissue sealants which allow for reduced surgery time, limited blood loss, easier tissue handling, and fewer postoperative complications. 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 ...
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