AAMI Agile Methods TIR – SoftwareCPR Presentation

The pdf at the link provided contains slides from a presentation by Brian Pate providing an overview of the soon to be released “Agile Methods for Medical Device Software Development” Technical Information Report (TIR). These slides focus on the TIR. We have posted another slide set in our library with some training slides on SoftwareCPR perspective on compliant and efficient use of Agile methods. Some of these concepts show up in the TIR as well, but not all. Brian and Alan Kusinitz assist companies in compliant and efficient use of Agile methods on a regular basis.

InvestigatingAgileCompliance-Pate-Workshop

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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