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 ...
In the test, the chemicals leaching off of the device are compared with a searchable database that provides background on toxicity and the Cramer classification. The proposed change in the standard ...
As regulatory scrutiny over device biocompatibility increases, MCRA forms a world class team of biocompatibility experts from FDA and industry. Key hires Eric M. Sussman, PhD, and Claus Svane ...
Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...
The evolution of medical-grade thermoplastic polyurethanes (TPUs) continues to reshape possibilities for device manufacturers seeking materials that combine flexibility, durability and ...
Ascend Performance Materials has launched a new portfolio of medical-grade nylon 6,6 resins and engineered materials for the healthcare market. The HiDura Med products meet ISO 10993-5 and 10993-10 ...
WASHINGTON, Aug. 16, 2022 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating US and International Regulatory, Clinical ...
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