Last Thursday, we conducted our second Managing Software Risk on the Road to FDA Compliance seminar. — this time in Minneapolis.
Like the Boston event last month, there was good discussion among participants and presenters regarding IEC 62304 and software development for medical devices.
I presented best practices around dynamic analysis and embedded software testing. Sharing the podium with me were Dan Sterling, president of SterlingTech and Todd Landry from Klocwork.
I found it interesting that at the Boston seminar there was a lot of discussion regarding Agile and test driven development. But when asked for a show of hands at this event, no one was even considering moving towards or adopting an Agile methodology. I’m not sure why such a difference. Todd wrote of his perplexity as well in his blog.
We also noted that in Boston, many of the participants were looking to adopt services to help with IEC 62304 compliance. Not so much here. I guess the lesson here, as always, is not to make assumptions about things.

In order to avoid the then-pending Noreaster that was barreling up the east coast toward New England, I had to travel to Minneapolis the night before my original departure schedule. After a very long evening of travel that included lots of delays and the de-icing of planes, I made it. I figured since I was speaking, I should do my best to get there!
It was snowing lightly in Minneapolis during the seminar. The city roads were not well plowed. However my rental car seemed to have no traction whatsoever. That wasn’t fun. When I stopped to fill up the tank, I checked the tires thinking they might be bald. No — the treads were packed with snow! That would explain the lack of traction!









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