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 ...

For years, the medical device industry has been expecting the alignment of FDA’s 21 CFR Part 820 quality system regulation (QSR) with the international ISO 13485 standard. FDA issued a proposed rule ...

Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to ...

Glucotrack, Inc., a medical technology company specializing in diabetes solutions, announced it has achieved ISO 13485:2016 certification from the British Standards Institute, marking a significant ...

The three-year transition period of ISO 13485:2016 officially comes to an end this month, but that deadline is almost meaningless at this stage. If you’re a medical device OEM doing business ...

In November 2023, we are proud to announce that we, Graylight Imaging, have successfully achieved ISO 13485 certified status, demonstrating our commitment to the highest quality standards in the ...

South African Health Products Regulatory Agency (Sahpra) has indicated that ISO 13485 certification is a prerequisite for the application or renewal of a medical-device license, with effect from 1 ...