FDA Presentation Intro to Regulated Software

The presentation “CDRH Regulated Software An Introduction” by John F. Murray Jr. CDRH Software Compliance Expert at FDA is a very good overview for those new to this topic. It covers device as well as production and quality system software, classification, and premarke review. The full presentation slides are at the link provided.

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
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