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 ...

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 ...

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 ...

Plastics possess many unique properties, can be used to make many different products and are highly manufacturable. These properties are being increasingly exploited in the production of medical ...

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 ...

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 ...