The ISO 13485:2016 training course presents a key market opportunity for medical device organizations to enhance their quality management systems, ensuring compliance with industry and regulatory ...
Collaboration underscores MethodSense’s role in accelerating market access and regulatory confidence for advanced ...
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...
After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally ...
Symphoni platform delivers real-time in-line quality assurance for medical devices, up to 320 parts per minute with 90% less ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Seno Medical has received CE Mark certification for its next-generation Imagio® Imaging System, Model 9100. EU MDR CE Mark indicates that a medical device meets the stringent safety, performance, and ...
ARLINGTON, Va.--(BUSINESS WIRE)--The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced today it ...
DONGGUAN, GUANGDONG, CHINA, January 15, 2026 /EINPresswire.com/ -- As global healthcare regulations tighten and patient ...
ARLINGTON, Va.--(BUSINESS WIRE)--The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has named Simon ...
DONGGUAN, GUANGDONG, CHINA, January 13, 2026 /EINPresswire.com/ -- The global health consciousness is increasing, and ...
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