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 ...

The medical technology industry has gone through some changes in the last 14 years, as has its regulatory environment, and it was time that ISO 13485 reflected that evolution. The global standard for ...

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 ...

This is the On-demand recording of The RAPS Philadelphia Chapter’s webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices. All medical device manufacturers supplying ...

Our recent interview with Garth Conrad, Vice President, Quality, at C.R. Bard, now part of BD, discussing the revision of ISO 13485, the international standard for medical device quality management ...