Day

August 6, 2019
Some thoughts on Requirements … using the General Principles of Software Validation to help. Many times we struggle with creating software requirements and documenting them.  The FDA General Principles of Software Validation-Final Guidance helps set the FDA expectations in this area.  Section 4.1 of the guidance states: “A documented software requirements specification provides a baseline for both...
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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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