Oura's ISO 13485 certification is the smart ring company's latest move to expand its software-as-a-medical-device (SaMD) ...
For years, the medical device industry has been expecting the alignment of FDA’s 21 CFR Part 820 quality system regulation (QSR) with the international ISO 13485 standard. FDA issued a proposed rule ...
Tec, Inc. ("n6"), maker of intelligent NGS library prep instruments, today announced that its quality management system has been certified to ISO 13485:2016 by Intertek, a leading global quality ...
Dublin, Feb. 13, 2025 (GLOBE NEWSWIRE) -- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets ...
This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated ...
How many people actually reread the minutes after a management review has concluded?The materials are thick. The ...
The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...
This Certification Evidences that RevBio is Implementing the Capabilities and Infrastructure Necessary for the Commercialization of its Platform of TETRANITE® Products LOWELL, Mass.--(BUSINESS ...
INDEPENDENCE, Ohio, Oct. 6, 2026 /PRNewswire/ -- GuidedSMILE™ has earned ISO 13485:2016 certification, an internationally recognized quality management standard specifically designed for organizations ...
Intertek registration of n6's quality management system covers the manufacture and service of instrumentation for genetic research PLEASANTON, Calif., Oct. 16, 2026 /PRNewswire/ -- n6 Tec, Inc. ("n6") ...
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