Scaling Software Agility

I 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 agree). The model has evolved and been refined based on peer reviewer feedback (thanks Gabor and [...]

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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 [...]

Filed under: Agile and FDA, High Assurance and Regulated Environments | 4 Comments »

In 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 (and other high assurance, high safety, high economic cost of failure) environments in an agile manner. [...]

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In 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. It’s not an idle thought. In the last 3-4 years, I’ve had the privilege of working [...]

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In the last post, I described an impressive Scrum of Scrums meeting I attended this week. It’s a pretty big Agile Release Train that has 14 cooperating teams. After just a few months of agile, this program really seems to be “on their game”, and this team clearly is developing some significant “ba”. I also [...]

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I was a “chicken” today at one of the more effective Scrum of Scrums for an Agile Release Train that I have witnessed. Big program. 14 teams. The uberScrumMaster (Release Team Manager) started the meeting at 9 am, facilitated the meeting and ran a pretty tight ship. Fourteen teams (2-3 remote) reported in a standard [...]

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Mike 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 development in this blog series). Specifically the AAMI (Association for the Advancement of Medical Instrumentation) is [...]

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Craig 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 into high assurance development.  Last month, Craig attended the first ever GE Agile Conference at the [...]

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In earlier posts in this series on Agile Development as Applied in High Assurance and Regulated Environments, I mentioned that applying agile development in the context of highly regulated environments is not a new thought, and at least some others have gone down this road before. And while the analysis of CFR 820.30 we did in [...]

Filed under: Agile and FDA, Case Studies, High Assurance and Regulated Environments | 7 Comments »