Additional Resources

  • AAMI. 2012. Guidance on the use of AGILE practices in the development of medical device software. 2012. AAMI TIR45 2012. This is the definitive reference for Agile in regulated industries at this time.

  • Collyer, Keith and Jordi Manzano. 2013. Being agile while still being compliant: A practical approach for medical device manufacturers. [Online] March 5, 2013. This readable case study describes how one team met regulatory requirements using an Agile approach.

  • Scaled Agile, Inc. 2017. “Achieving Regulatory and Industry Standards Compliance with the Scaled Agile Framework® (SAFe®)” Scale Agile, Inc. White Paper, August 2017. This white paper describes how to achieve compliance using SAFe as the specific approach to Agile. It is short and a good complement to this chapter.

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