High Assurance Series Update

Posted on August 26, 2011 by Dean Leffingwell in High Assurance and Regulated Environments

A few quick notes to those interested in the agile and high assurance and regulated environments series..

Whitepaper Update

A draft of our whitepaper Agile Software Development with Verification and Validation in High Assurance and Regulated Environments was made available to attendees at Agile 2011 the week before last. If you’d like a copy, please contact Craig Langenfeld at Rally Software (clangenfeld@rallydev.com). The final paper will be released in mid to late September. When it is, I’ll post a copy here.

Upcoming Webinar

Rally Software just announced a webinar on this very topic:

Agile in High Assurance and Regulated Environments: September 27th – EMEA 15:00 (GMT + 01:00), 10am ET / 7am PT September 27th – Americas 1pm ET / 10am PT.

Craig and I, along with another industry expert, will be covering this topic in a one hour webinar. You can register here:

Upcoming AAMI report : Guidance on the use of agile practices in the development of medical device software.

A month or so back, Mike Russell sent me a draft of the upcoming AAMA (Association for the Advancement of Medical Instrumentation) Technical Information Report of the title above.

I reviewed the report and it is exceedingly well done. It provides a comprehensive view of adapting agile practices in the context of regulated medical device development, including an analysis of the impact on the company’s quality management system. Whether intended or not, it also provides a detailed look at high quality agile practices, so it can serve as a bit of a primer for those in the industry who are not familiar with Agile development. I suspect this will be a pivot point in the movement to agile in this industry, as it is specific enough to provide excellent guidance for those making this transition.

Upcoming AAMI TIR

Mike notes that “the report is currently in the working draft stage, preceding the formal first committee draft, that is due out probably early September.”

Scaled Agility Framework for High Assurance Development

Finally, in prepping for the upcoming webinar, I put together this version of the Big Picture Scaled Agility Framework. The changes aren’t that significant, but they may be material (and perhaps helpful) to anyone following this blog series.