FDA Technical Reference on Software Development

FDA Office of Regulatory Affair’s “TECHNICAL REFERENCE ON SOFTWARE DEVELOPMENT” issued July 1, 1987 as guidance to inspectors regarding software. This guidance is dated but still sometimes referenced in other publications. It provides some textbook type information as educational material for use in inspections but is no longer heavily utilized.

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 4-6, 2020

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