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September 13, 2022
FDA Issues Draft Guidance on Computer Software Assurance for Production and Quality System Software The U.S. Food and Drug Administration (FDA) issued the new draft guidance: Computer Software Assurance for Production and Quality System Software. Download here: 2022-Guidance-Computer-Software-Assurance This new FDA draft guidance provides recommendations on risk-based assurance activities for computers and automated data processing systems that are...
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Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
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