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 ...

Certification of a robust and compliant Quality Management System for AI-based Software as Medical Devices, as per internationally recognized medical device regulatory standards Pledge of quality to ...

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 ...

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 ...

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 ...

Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed ...

This Certification Evidences that RevBio is Implementing the Capabilities and Infrastructure Necessary for the Commercialization of its Platform of TETRANITE® Products LOWELL, Mass.--(BUSINESS ...

Certification to ISO 13485 extended to also include production process Supports Bentrio growth strategy together with strategic contract manufacturer and expanding network of international ...

SOPHIA-ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI)-powered ...

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 ...