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 ...

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 ...

The evolution of medical-grade thermoplastic polyurethanes (TPUs) continues to reshape possibilities for device manufacturers seeking materials that combine flexibility, durability and ...

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, ...

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 ...

Nuremberg, Germany May 14, 2013 – Cymbet Corporation announced today at the PCIM Europe show the successful results of in vivo biocompatibility feasibility studies that were conducted to evaluate the ...

The main theme running through FDA's guidance on ISO 10993-1 is that every medical device should be assessed for its specific risk to the end user. Audrey Turley and Thor Rollins In June 1906, ...

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 ...