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 ...

We are excited to bring this service in house as means to better serve our clients as we can now offer a comprehensive test program for plastic and elastomer components in a more cost-effective and ...

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 ...

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 ...

Brinkman brings more than 15 years of experience in biological sciences and is known for her rigorous, clinically relevant approach to biological risk evaluation BOENNIGHEIM, Germany and LIGONIER, Ind ...

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 ...