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 ...
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, ...
SPENCER, Mass.--(BUSINESS WIRE)--FLEXcon, an innovator in adhesive coating and laminating, today announced it has launched the company’s dermaFLEX™ line of adhesives that meet the ISO 10993 ...
Silicone elastomers are well accepted in the healthcare industry. They meet biocompatibility standards and have advantageous properties like purity, clarity, strength, and chemical compatibility, as ...
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 ...
In April 2013, FDA released draft guidance for industry and FDA administration staff titled “Use of International Standard ISO 10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and ...
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 ...