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 ...

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.

The MarketWatch News Department was not involved in the creation of this content. Pneumeric Inc. has been successfully certified to ISO 13485:2016 (Quality Management System) by Perry Johnson ...

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

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 ...

The company advances precision CNC machining for medical device components with ISO 13485–aligned quality control and traceable manufacturing processes. CA, UNITED ...

Dublin, Jan. 27, 2026 (GLOBE NEWSWIRE) -- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course (May 21, 2026)" training has been added to ...

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 ...