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 ...

Brinkman brings more than 15 years of experience in biological sciences and is known for her rigorous, clinically relevant approach to biological risk evaluation "We're thrilled to welcome Katie to ...

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 ...

As medical device toxicology requirements continue to evolve, MCRA hires board certified toxicologist Sharlee More, PhD, DABT. Dr. More expands MCRA's biocompatibility services to include ...

Experts trace the harmonization of Japanese, FDA, and ISO guidelines on biocompatibility testing, as well as key disparities to know. Zhenghong Tao, Laurence Lister, and Keisuke Suzuki The process of ...

MILPITAS, Calif.--(BUSINESS WIRE)--SMI (Silicon Microstructures, Inc.) is pleased to announce that biocompatibility of IntraSense™ has been confirmed at a major medical device manufacturer.

Biocompatibility testing is performed on medical devices to ensure that they will not cause any adverse effects once in contact with or implanted into a patient, and as a standard, all such devices ...

Medical devices play an essential role in improving the quality of human life. Consequently, their design poses unique engineering challenges. Designers must address high standards of reliability, ...