Articles & White Paper Reprints

This is a list of ONLY SOME of the most popular software related articles and white papers on our website; additional ones can be found be searching our library. All reprints not copyrighted by SoftwareCPR are provided with permissions of the authors or publishers unless they are government issued public information. Please respect the copyrights. The articles cover a wide range of subjects and we encourage submission of white papers or articles for posting.

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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