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 ...
BUFFALO GROVE, ILLINOIS / ACCESS Newswire / February 4, 2026 / PPC Flex, a leader in high-performance sterile and cleanroom flexible packaging solutions, is proud to announce that its Buffalo Grove ...
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 ...
Glucotrack, Inc., a medical technology company specializing in diabetes solutions, announced it has achieved ISO 13485:2016 certification from the British Standards Institute, marking a significant ...
ESCATEC secures ISO 13485 for UK facility, advancing global medtech capability Lutterworth, UK — Growth focused electronics ...
New generations of small medical electronics devices demand the highest levels of quality and reliability For EMS providers and contract manufacturers, the International Standards Organization (ISO) ...
CLEVELAND--(BUSINESS WIRE)--KeborMed, the connected care platform, announced today it attained the ISO 13485 certification for its quality management system. This milestone marks a significant step in ...
Ducor Petrochemicals, a global partner in the development of polypropylene plastics, has developed a product range that is specifically designed for the production of medical devices and other Life ...
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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