Overview: ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus ...

Globally, the medical industry is continuously growing and is highly dependent on technological advancements and essential procedures aimed at producing the best treatments. To make sure proper ...

Introduces early stage audit readiness solutions to streamline ISO 13485 certification for medical device and IVD companies inline with MDR, IVDR and FDA QMSR CHARLOTTE, NC, UNITED STATES, April 29, ...

This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485.

DUBLIN--(BUSINESS WIRE)--The "Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation" training has been added to ResearchAndMarkets.com's offering. The new medical device regulation EU MDR ...

FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...