The U.S. Food and Drug Administration (FDA) published an updated final guidance on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and ...
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 ...
Experts trace the harmonization of Japanese, FDA, and ISO guidelines on biocompatibility testing, as well as key disparities to know. Zhenghong Tao, Laurence Lister, and Keisuke Suzuki The process of ...
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