Day

March 8, 2016
Click here to view a summary of my highlights and rationale, along with some practical implementation tips for the new ISO 13485:2016:  SoftwareCPR-ISO13485 revision March 2016 highlights Some of the revisions add items included in FDA’s 21 CFR 820 Quality System Regulation such as Design Transfer, Validation of automation of quality system activities, detailed records, and...
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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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