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Archive of High Assurance and Regulated Environments
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Agile Crosses the Chasm to….DoD?
Posted on January 3, 2011 by Dean Leffingwell in High Assurance and Regulated EnvironmentsI recently received an email from Dr. David F. Rico, (PMP, CSM) regarding the recent AFEI DoD Agile Development Conference, held on Tuesday, December 14, 2010 in Alexandria, Virginia. "The purpose of the conference was to promote agile acquisition...
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Additional Perspective on Agile, V&V and FDA
Posted on December 27, 2010 by Dean Leffingwell in Agile and FDABrian 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...
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Software Verification and Validation in High Assurance Agile Development: Verification: SRS and User Stories
Posted on December 17, 2010 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsSeries 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...
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Software Verification and Validation in High Assurance Agile Development: Ground Rules
Posted on December 4, 2010 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsSeries 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...
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Updated Agile Requirements Metamodel (Enterprise Backlog Model)
Posted on November 29, 2010 by Dean Leffingwell in Agile and FDA, Agile Requirements, High Assurance and Regulated EnvironmentsI was walking through some blog posts in the requirements category today looking for a later version of the full "agile requirements metamodel". (Some readers commented that "enterprise backlog model" might be a better descriptor, and I tend to...
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Software Verification and Validation in High Assurance Agile Development: Definitions
Posted on November 28, 2010 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsSeries 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...
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An Iterative and Incremental Process Model for Agile Development in Regulated Environments
Posted on November 23, 2010 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsIn this series of posts, I’ve been using Medical Device Development (as Regulated by US FDA via CFR 820.30, and internationally as regulated by IEC 62304) as an exemplar for suggesting ways to develop high quality software in regulated...
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High Assurance Agile Software Development in Medical Devices: Prove It
Posted on November 22, 2010 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsIn this series of posts, I’ve been laying the background for describing a set of practices that I believe can help development teams working in high assurance and regulated industries build the highest quality software possible…. using agile methods...
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Upcoming AAMI Technical Information Report on Agile and Medical Device Software
Posted on November 7, 2010 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsMike Russell and Brian Lewis Pate of SoftwareCPR.com just informed me of an important new development with respect to the use of agile in medical device development (we are using medical device development as the exemplar for high assurance...
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More Agile Momentum in Healthcare: GE Agile Conference
Posted on November 5, 2010 by Dean Leffingwell in Agile and FDA, High Assurance and Regulated EnvironmentsCraig Langenfeld, of Rally Software, (Craig has been providing some thought leadership and has been working directly with me on this blog series) just brought me up to date on another leading indicator of agile’s march across the chasm...
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