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 ...
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 ...
Salt Medical today announced it has achieved ISO 13485:2016 certification, the internationally recognised standard for ...
In November 2023, we are proud to announce that we, Graylight Imaging, have successfully achieved ISO 13485 certified status, demonstrating our commitment to the highest quality standards in the ...
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 ...
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) ...
Light AI Inc. ("Light AI" or the "Company") (CBOE CA: ALGO) (FSE: OHC) (OTCQB: OHCFF) an artificial intelligence health technology company developing Software as a Medical Device ("SaMD") solutions, ...
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 ...
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 ...
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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