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 ...
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, ...
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 ...
The evolution of medical-grade thermoplastic polyurethanes (TPUs) continues to reshape possibilities for device manufacturers seeking materials that combine flexibility, durability and ...
Trivitron Healthcare’s Imaging Division, Kiran Medical Systems has announced that Kiran’s radiation protection products have been tested and proven to be compliant with International biocompatibility ...
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 ...
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