The attempt by the U.S. FDA to harmonize its Quality System Regulation (QSR) with ISO 13485 promises to be a difficult slog, but Jeff Shuren, director of the agency’s device center, said the agency is ...
Asuragen, Inc., today announced that it has received ISO 13485 and 9001 certification for the quality management system for its medical devices. Asuragen undertook the more rigorous medical device ...
DUBLIN--(BUSINESS WIRE)--The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.
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 ...
BURLINGTON, ONTARIO--(Marketwired - Nov 25, 2014) - Etratech Inc., a global leader in the design, development and manufacture of advanced electronic controls and control systems for major ...
Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to ...
WINNIPEG, Sept. 14, 2017 /PRNewswire/ - Precision ADM Inc. is pleased to announce that it is the first Canadian metal Additive and Subtractive manufacturing services company to receive ISO 13485:2016 ...
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 ...
Certification enhances global market readiness, reinforces quality systems, and supports Zomedica's long-term growth strategy ANN ARBOR, MI / ACCESS Newswire / November 6, 2025 / Zomedica Corp. (OTCQB ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback