Day

July 21, 1997
3. Failure to maintain written validation protocol and procedures for software and hardware maintenance for the _____ computer system version _____ . 4. Failure to have documented validation for the _____ software and the _____ software. Observation #12. Security controls should be established in writing. They should address the automated test system, as well as...
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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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