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 ...
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 ...