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.
U.S. and EU regulators require human factors and usability testing to bring a medical device to market. Virginia Lang, PhD, president and chief scientist at HirLan Inc., an engineering consultancy ...
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, ...
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 ...
The evolution of medical-grade thermoplastic polyurethanes (TPUs) continues to reshape possibilities for device manufacturers seeking materials that combine flexibility, durability and ...
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 ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...