Eurofins Medical Device Services North America, part of a global network of over 20 medical device testing laboratories and a leading medical device solutions partner, recently launcheda GMPPFAS ...
AUSTIN, Texas--(BUSINESS WIRE)--atsec AB Stockholm, Sweden is thrilled to announce: We are the first IEEE Authorized Testing Facility! We've officially been approved as an IEEE Authorized Testing ...
As data-driven innovation profoundly changes every industry, the healthcare sector is also affected. Digital twins – virtual copies of physical devices – are essentially changing the ...
TOLEDO, Ohio--(BUSINESS WIRE)--NAMSA, a world-leading MedTech testing, clinical and regulatory consulting firm, announced today that it has entered into a definitive agreement to acquire the U.S.
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, ...
In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...
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 ...
The integration of artificial intelligence (AI) into the design of medical devices heralds a new era in healthcare—one where innovation meets precision to significantly enhance patient outcomes. This ...
DNV is a trusted Notified Body for medical device certification under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). We provide independent, rigorous, and ...
Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...
"A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the ...
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