Dublin, Oct. 17, 2025 (GLOBE NEWSWIRE) -- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course (Nov 20, 2025)" training has been added to ...

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 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 ...

BOULDER, Colo., Jan. 25, 2023 /PRNewswire/ -- ISO 13485 is an internationally recognized standard that sets out the requirements for a quality management system for the medical device industry. Our ...

SALT LAKE CITY, UTAH / ACCESSWIRE / December 16, 2024 / Hoggan Scientific, LLC, a globally recognized leader in the design and manufacture of medical devices, is proud to announce that it has ...

SAN FRANCISCO--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (“Tivic”) (Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today ...

BORDEAUX, France--(BUSINESS WIRE)--FineHeart S.A, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, a fully Implantable Cardiac Output Management System designed to address ...

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

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.

Hoggan Scientific, LLC, a globally recognized leader in the design and manufacture of medical devices, is proud to announce that it has successfully received recertification for ISO 13485:2016, the ...