FDA DSMA Quality System Manual Chapter 7

Chapter 7 of FDA CDRH’s division of small Manufacturers Assistance “Medical Device Quality Systems manual: A small entity Compliance Guide”. this manual was issued in December of 1996 shortly after release of the final version of the Quality System Regulation. It was intended to help explain the Quality System Regulation and how to comply with its requirements. Chapter 7 is titled “Equipment and Calibration “. Section 7-1 through 7-8 address software used in the production and quality system and has some interesting things to say about CNC equipment.

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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