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 ...
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 ...
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 ...
The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which ...
Salt Medical today announced it has achieved ISO 13485:2016 certification, the internationally recognised standard for quality management systems for the medical device industry.
The 2003 version of ISO 13485 is organized differently than the 1996 version. Much of the change is related to the prescribed process approach (as opposed to procedures or elements) and such a ...
The U.S. Food and Drug Administration has implemented its revised Quality Management System Regulation (QMSR), effective February 2, 2026, aligning medical device manufacturing requirements with the ...
This Certification Evidences that RevBio is Implementing the Capabilities and Infrastructure Necessary for the Commercialization of its Platform of TETRANITE® Products LOWELL, Mass.--(BUSINESS ...
Earnings Call Insights: NeuroOne Medical Technologies Corporation (NMTC) Q2 fiscal 2026 “Product revenue for the OneRF brain ablation system in the second quarter of fiscal 2026 grew 72% ...
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