AAMI Software Standard Comment Resolutions6/29/00

The AAMI “Medical Device Software — Software life cycle processes” SW 68 draft has been revised based on comments from the committee ballot earlier this year. (The revised standard is also available on this site in the library section). The link provided contains the comment by comment revised comment resolutions from the earlier draft.

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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