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At AAMI’s International Standards Conference on March 11 2003 FDA’s CDRH Software Compliance Expert and AAMI Software Committee co-chair (John Murray) gave a presentation on FDA’s software message and the role standards can play to benefit industry and FDA.
Alan Kusinitz of SoftwareCPR and co-chair of the AAMI working group on Software Hazard Management provided an update on the status of this effort and the current content of a technical information report. Sherman Eagles of Medtronic and AAMI Software Committee co-chair gave a presentation on software standards for medical devices and provided an overview of the international work on 62304 which is based on the AAMI SW68 software standards.
The slides from these presentations are available at the links below:
John Murray’s Software Standards Presentation
A. Kusinitz Presentation – Software Hazard Management TIR
Sherman Eagle’s Presentation on Software Standards and 62304 Status