Several months after the US Food and Drug Administration (FDA) announced the first wave of testing laboratories accredited under its accreditation scheme for conformity assessment (ASCA) pilot, the ...

The US Food and Drug Administration (FDA) has updated and expanded its list of premarket medical device consensus standards that include important topics such as medical device cybersecurity, ...

FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

Designing a medical device? This whitepaper helps you evaluate adhesive options for biocompatibility, sterilization resistance, and manufacturability — so you can make the right material decision ...

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 ...

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 ...

MOORESVILLE, NC - April 06, 2026 - PRESSADVANTAGE - Advanced Industrial, a precision CNC plastics machining company ...

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 ...