Posts Tagged ‘FDA’

  • Medical Devices Roadshow – Minneapolis style

    on Jan 14, 11 • by Todd Landry • with No Comments

    Medical Devices Roadshow – Minneapolis style

    Yesterday we did our second Medical Devices software seminar, this time in snowy and cold Minneapolis. Say what you will about the weather, but this city is built for winter…it has various overhead ‘tunnels’ called ‘skyways‘ connecting what seemed to be the entire downtown core, so you rarely ever need to go outside. Anyways, our seminar drew the interest of over 75% of registrants, mostly software engineers and QA, so really another great turnout. The format was the same as our Boston event, with the same players from SterlingTech, Klocwork (duh) and Vector Software. There

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  • Software Development for Medical Devices Seminar

    on Dec 17, 10 • by Todd Landry • with 2 Comments

    Software Development for Medical Devices Seminar

    Yesterday we kicked off our first Medical Devices specific seminar in Boston, with our friends from SterlingTech and Vector Software. The day was all about software development for medical devices and more specifically, about managing software risk to help ensure you are compliant with all of the FDA regulations specific to software code. We had a great turnout, with over 75% of registrants showing up for this session. A couple of observations I found interesting from this event: The medical devices community seems to be fairly tight-knit. Everyone at the event seemed to know everyone else, and

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  • Agile 2009… Day 4

    on Aug 27, 09 • by Brendan Harrison • with 2 Comments

    Main topic of today is using Agile in an FDA regulated medical device context. Sounds like an impossibility I know, but the folks from Agiletek and Abbott presented a very interesting case study on how they did it. They started off by presenting “the way it used to work”, highlighting an older product development cycle from the 1990s that had very strictly defined dev phases, including a 10-12 week integration cycle – yikes! When they decided to implement Agile on a more recent project they broke up their 3-5 year dev cycle in 6 week

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  • Klocwork at Agile 2009 in Chicago…

    on Aug 21, 09 • by Brendan Harrison • with No Comments

    Off to Agile 2009 next week in Chicago where Klocwork will be both attending and exhibiting at the conference. We’ll blog throughout the week to keep people updated and let you know the latest. There are a few sessions in particular that we’ll be sure to report on and let readers know anything useful we learned (or not): Adopting Agile in an FDA Regulated Environment Java and Ruby Tools for Code Quality Effective Code Reviews in Agile Teams Zen and the Art of Software Quality Scrum and CMMI – from Good to Great Be sure

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