divendres, 10 d’abril del 2015

IMDRF weighs in on QMS requirements for software as a medical device




The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.





Emergo Group

By Stewart Eisenhart, Emergo Group


The International Medical Device Regulators Forum (IMDRF) has published new guidelines for how software developers whose products are considered medical devices may be affected by quality management system regulations that currently apply to more conventional device manufacturers.




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