EU Medical Device Software Regulation Article

A white paper at the link provided gives an overview of the status of European Union medical device software regulation and provides suggestions on software validation. Some of the suggestions are based on FDA guidance documents. CMD Swartikel

This paper was provided by Poul Schmidt-Andersen of Copenhagen Medical Devices which is an affiliate of SoftwareCPR.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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