Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

Dublin, June 28, 2024 (GLOBE NEWSWIRE) -- The "The US FDA QMSR Transition - 21 CFR 820 and ISO 13485" training has been added to ResearchAndMarkets.com's offering. The US FDA, after years of ...

The "ISO 13485: Quality Management Systems for Medical Devices" conference has been added to ResearchAndMarkets.com's offering. This seminar has been designed to provide a comprehensive overview into ...

The 2003 version of ISO 13485 is organized differently than the 1996 version. Much of the change is related to the prescribed process approach (as opposed to procedures or elements) and such a ...

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.

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 ...

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 enhances global market readiness, reinforces quality systems, and supports Zomedica's long-term growth strategy ANN ARBOR, MI / ACCESS Newswire / November 6, 2025 / Zomedica Corp. (OTCQB ...

The "The US FDA QMSR Transition - 21 CFR 820 and ISO 13485" training has been added to ResearchAndMarkets.com's offering. The US FDA, after years of discussing the harmonization of 21 CFR 820, Device ...

The ISO 13485:2016 standard specifies requirements for a Quality Management System (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that ...