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 ...
Global ISO Training Provider Audit Workshop Adds Courses for ISO 13485, ISO 37001 and ISO 19011:2026
New self paced online courses cover medical device quality management, anti bribery management and management system auditing. ISO 13485 is the international standard for quality management systems in ...
The FDA's 21 CFR Part 820 and ISO 13485 are crucial in regulating medical device quality systems. Harmonizing these standards by 2026 will streamline compliance, improve patient access to devices, and ...
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 ...
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 ...
ZAVENTEM, Belgium, May 20, 2025 (GLOBE NEWSWIRE) -- SYNDEO Medical, a Belgian-based developer of interventional procedure solutions, is pleased to announce that it has received ISO 13485 certification ...
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 ...
YORBA LINDA, Calif., June 2, 2022 /PRNewswire/ -- Previon has achieved ISO 13485 certification from NSF-ISR, an NSF company. The ISO 13485 standard is the quality management systems standard for 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 ...
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