62304 CMMi Comparison Article

For those using or interested in the SEI’s Capability Maturity Model, the link provided contains a white paper comparing IEC 62304 and the CMMi. This white paper was prepared by David Walker, a consultant that is a licensed SEI partner. It is published here with his permission.

62304-CMMi-comparison-DWalker092909

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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