Additional Perspective on Agile, V&V and FDA

Brian Shoemaker, Ph.D., who clearly has expertise on software quality and FDA, (see http://www.shoebarassoc.com/; Brian has more than thirteen years’ experience with software quality and validation in the FDA-regulated industry) added an in-depth comment describing additional documentation guidance for doing software V&V. He also provides  his opinion on applicability of agile in this world (just do it?) [...]

Software Verification and Validation in High Assurance Agile Development: Verification: SRS and User Stories

Series 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 high assurance, high economic cost of failure) environments in an agile manner. This series is [...]

Software Verification and Validation in High Assurance Agile Development: Ground Rules

Series 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 high assurance, high economic cost of failure) environments in an agile manner. This series is [...]

Resource Flexibility in The Agile Enterprise

I received this interesting email from a colleague (who allowed me to share it) a few days back. “I currently lead a project on how to increase our resource fluidity so that we can effectively assign sufficient manpower to where it matters the most, e.g. working on the highest priority items on the backlog. We acknowledge [...]

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