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 ...
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, ...
Hohenstein Medical is a global, best-in-class GLP-certified and ISO/IEC 17025-accredited laboratory, conducting biocompatibility testing for medical devices, including chemical screenings, biological ...
The contract research organization will launch an expanded ISO 18562 gas pathway testing program and ISO 10993-18 particulate ...
The U.S. Food and Drug Administration (FDA) published an updated final guidance on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and ...
Medical Device Network on MSN
NAMSA acquires Labcorp’s medical device testing assets
The move adds Labcorp’s US biocompatibility, analytical testing, and preclinical research services to Namsa’s operations.
The evolution of medical-grade thermoplastic polyurethanes (TPUs) continues to reshape possibilities for device manufacturers seeking materials that combine flexibility, durability and ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the availability of its robust In Vitro Micronucleus Test service to meet the ...
NEW BRIGHTON, Minn.--(BUSINESS WIRE)--TÜV SÜD announces its plans to expand its Medical & Health Services (MHS) facilities in New Brighton, Minnesota, during a groundbreaking ceremony. This 20,000 ...
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