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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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email for more info.

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