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 ...

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 ...

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 ...

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.

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "ISO 13485 2016-Quality management systems - Requirements for regulatory purposes - Webinar" webinar to their offering.

Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...

Our recent interview with Garth Conrad, Vice President, Quality, at C.R. Bard, now part of BD, discussing the revision of ISO 13485, the international standard for medical device quality management ...

Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system. ISO 13485, the ISO standard for medical device quality ...

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 ...