Day

November 20, 2006
Sherman Eagles, a Medtronic Standards representative and co-chair of the AAMI software committee, gave a presentation on changes and new developments in software standards at the Nov 2006 Advamed conference. This presentation is at the link provided. It addresses the withdrawal of ISO/IEC 60601-1-4 and the incorporation of Programmable Electronic Medical Systems (PEMS) into the...
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/docs/IVDDFDARegulationofSoftwarePresentation1106.pdf
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Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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