June 24, 2000
The link above provides the slides and notes of a presentation made by David Manalan reqarding FDA’s Quality System Inspection Technique. David is an associate of SoftwareCPR and you can reach him at or 978-266-1220. BOSCON manalan QSIT
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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:

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