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 ...

Biocompatibility testing is performed on medical devices to ensure that they will not cause any adverse effects once in contact with or implanted into a patient, and as a standard, all such devices ...

However, that costs time and money, and the document looks the same as the one on the FDA Web site. Due to the lack of easily obtainable information, an engineer or regulatory affairs officer may ...

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 ...