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 ...

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 ...

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 ...

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 ...

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 ...

The current medical device Quality Management System (QMS) standard ISO 13485: 2016 does not address the specific requirements of a cyber device. In this session, we intend to answer the question that ...

Kimera Labs, Inc., a clinical-stage biotechnology company specializing in the research and manufacture of placental mesenchymal stem cell-derived exosomes, today announced the integration of three ISO ...

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 ...