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This whitepaper is taken from Chapter 18 of Scaling Software Agility.

Taken from Chapter 7, The Rational Edge of Scaling Software Agility.

Background: In this series of posts, I’ve been using medical device development (as Regulated by U.S. FDA via CFR 820.30 and international standard IEC62304) as an exemplar for suggesting ways to develop high quality software in regulated (and other...
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