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Blogs about: High Assurance And Regulated Environments

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New Whitepaper: Agile and High Assurance4 comments

Dean Leffingwell wrote 6 months ago: Finally. For those who have been following the High Assurance and Regulated Environments series, I a … more →

Tags: Agile and FDA, High Assurance and Tooling

High Assurance Series Update

Dean Leffingwell wrote 9 months ago: A few quick notes to those interested in the agile and high assurance and regulated environments ser … more →

HIgh Assurance Series Update

Dean Leffingwell wrote 10 months ago: I haven’t posted much in this category lately as I’ve been busy drafting and redrafting … more →

Tags: Agile and FDA, High Assurance and Tooling

Tooling for User Story Verification, Part 2

Dean Leffingwell wrote 1 year ago: Note: This post is a continuation of the series on Agile in High Assurance and Regulated Environment … more →

Tags: Agile and FDA, High Assurance and Tooling

Tooling to Automate User Story Verification

Dean Leffingwell wrote 1 year ago: In a recent post, I noted that Craig Langenfeld, my co-contributor on the Agile in High-Assurance an … more →

Tags: Agile and FDA, High Assurance and Tooling

Agile Tooling for High Assurance Development Series: Intro

Dean Leffingwell wrote 1 year ago: For those who have been following the High Assurance and Regulated Environments and Agile and FDA se … more →

Tags: Agile and FDA

Software V&V in High Assurance Agile: Validation: Nonfunctional Requirements

Dean Leffingwell wrote 1 year ago: Background: In this series of posts, I’ve been using medical device development (as Regulated by U.S … more →

Tags: agile requirements, Agile and FDA

Software V&V in High Assurance Agile: Verification: Testing Features3 comments

Dean Leffingwell wrote 1 year ago: Background: In this series of posts, I’ve been using medical device development (as Regulated by U.S … more →

Tags: Agile and FDA

Software V&V in High Assurance Agile Development: Verification: PRD, Features and PRD to SRS Traceability

Dean Leffingwell wrote 1 year ago: Background: In this series of posts, I’ve been using medical device development (as Regulated by U.S … more →

Tags: Agile and FDA

Software Verification and Validation in High Assurance Agile Development: Validation Sprint

Dean Leffingwell wrote 1 year ago: Series Background: In this series of posts, I’ve been using medical device development (as Regulated … more →

Tags: Agile and FDA

Agile Crosses the Chasm to....DoD?

Dean Leffingwell wrote 1 year ago: I recently received an email from Dr. David F. Rico, (PMP, CSM) regarding the recent AFEI DoD Agile … more →

Software Verification and Validation in High Assurance Agile Development: Verification: SRS and User Stories1 comment

Dean Leffingwell wrote 1 year ago: Series Background: In this series of posts, I’ve been using Medical Device Development (as Regulated … more →

Tags: Agile and FDA

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

Dean Leffingwell wrote 1 year ago: Series Background: In this series of posts, I’ve been using Medical Device Development (as Regulated … more →

Tags: Agile and FDA

Updated Agile Requirements Metamodel (Enterprise Backlog Model)3 comments

Dean Leffingwell wrote 1 year ago: I was walking through some blog posts in the requirements category today looking for a later version … more →

Tags: agile requirements, Agile and FDA

Software Verification and Validation in High Assurance Agile Development: Definitions4 comments

Dean Leffingwell wrote 1 year ago: Series Background: In this series of posts, I’ve been using Medical Device Development (as Regulated … more →

Tags: Agile and FDA

An Iterative and Incremental Process Model for Agile Development in Regulated Environments2 comments

Dean Leffingwell wrote 1 year ago: In this series of posts, I’ve been using Medical Device Development (as Regulated by US FDA via CFR … more →

Tags: Agile and FDA

High Assurance Agile Software Development in Medical Devices: Prove It

Dean Leffingwell wrote 1 year ago: In this series of posts, I’ve been laying the background for describing a set of practices that I be … more →

Tags: Agile and FDA

Upcoming AAMI Technical Information Report on Agile and Medical Device Software5 comments

Dean Leffingwell wrote 1 year ago: Mike Russell and Brian Lewis Pate of SoftwareCPR.com just informed me of an important new developmen … more →

Tags: Agile and FDA

More Agile Momentum in Healthcare: GE Agile Conference2 comments

Dean Leffingwell wrote 1 year ago: Craig Langenfeld, of Rally Software, (Craig has been providing some thought leadership and has been … more →

Tags: Agile and FDA


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