Dublin, April 13, 2026 (GLOBE NEWSWIRE)-- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices (May 21, 2026)" training has been added to ...

Have you started implementing ISO 13485:2016 yet? If not, I’m afraid I have to tell you that you’re lagging behind at this point. You have one year to go before compliance is an absolute requirement.

One of the main changes to ISO 13485:2016 “Medical devices -- Quality management systems – Requirements for regulatory purposes” pertaining to suppliers is the “increased emphasis on use of a ...

This course covers changes from ISO 13485:2003 to the ISO 13485:2016 standard and their impact on a company’s Quality Management System (QMS). Topics include the Annex SL framework, methods for ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) today announced that the company has received ISO 13485:2016 certification for its Quality Management System (QMS) for 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 ...

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 ...

The FDA has notified the medical device manufacturing sector that ISO-13485(2016) will be recognized as a Quality Management System Consensus Standard. In February 2026, the FDA will move away from ...