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A Comparison of Software Development Methods in a Regulated and Commercial Environment

Summary: [This abstract is based on the author's abstract.]Software development practices used in regulated environments are compared with those used in commercial applications. Tradeoffs are explained, and it is shown that a common risk-based strategy can have significant applicability in both situations. A cautionary note is given regarding the use of standards, and lessons learned in both environments are discussed.

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  • Topics: Product Development and Recall, Software Quality
  • Keywords: Lessons learned,Medical devices,Product development,Regulations,Risk analysis,Software configuration management,Validation
  • Author: Olivier, Daniel P.
  • Journal: Software Quality Professional Magazine