The document, which the FDA released Thursday, is the regulator's response to deficiencies it said it often sees in premarket submissions. Lab-to-lab variability in approaches to analytical chemistry ...

Dublin, Oct. 26, 2021 (GLOBE NEWSWIRE) -- The "Biocompatibility Testing Services for Medical Devices Market: Global Industry Analysis, Trends, Market Size, and Forecasts up to 2027" report has been ...

Image of an in vitro irritation test courtesy Nelson Laboratories. Biocompatibility testing requirements for medical devices are changing. "A lot of things are happening, on all fronts," Thor Rollins, ...

Intramuscular implantation assesses local tissue response to an implanted material for the ISO 10996-6 implantation test. However, manufacturers are on their own when it comes to how best to fulfill ...

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 ...

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 ...

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 ...

STEMart announces the expansion of its genetic toxicology capabilities with the In Vivo Rat Micronucleus Test services. NEW YORK, NY, UNITED STATES, January 26, 2026 ...

The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that may not be biocompatible for use in ...

TOLEDO, Ohio--(BUSINESS WIRE)--NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today that the U.S.