Day

September 30, 2019
August and September 2019 continued a busy trend of regulatory and compliance activity – there were 42 software related recalls!  We also announced our 2020 Public Training Course dates!  Onward to higher software quality – keep pressing forward!
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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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