The main market opportunities lie in developing training programs and consulting services to help medical device manufacturers comply with ISO 13485 and 21 CFR 820, particularly focusing on effective ...

The new ISO 9001:2015 standard and the anticipated reboot of ISO 13485 could create hurdles for medical device manufacturers. Thomas C. Bowles Recent months have seen extraordinary changes in the ...

WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that it has successfully achieved ISO 13485:2016 Medical Device Quality ...

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

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.

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 ...

Asuragen, Inc., today announced that it has received ISO 13485 and 9001 certification for the quality management system for its medical devices. Asuragen undertook the more rigorous medical device ...