On 10/23/03, Alan gave a presentation on risk based approaches to Part 11 as recommended in the final FDA guidance. A copy of the slides are at the link provided. Also available on the site are the slides from Joe Famulare (FDA’s Part 11 lead) presented at this conference.
IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.
October 13-15, 2026
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