Software Testing for Medical Devices Seminar

Lynda Gaines

December 20, 2010

Last Thursday, I participated in a joint seminar with two of our partners: SterlingTech Software and Klocwork. The Managing Software Risk on the Road to FDA Compliance seminar was the first of a series, specifically targeted to organizations developing and testing software for medical devices. The presentations focused on managing risk and ensuring compliance with FDA and IEC 62304 software development guidelines. The presentations were well received and worked really well together. The first one, presented by SterlingTech, was on IEC 62304 and what medical device companies need to do to conform to this and other related standards when developing their products for FDA certification. Next, Klocwork presented information on static analysis strategies that tie into IEC 62304. I “batted clean-up”, discussing strategies to achieve FDA software validation compliance. There were about 20 attendees in the room from over 10 different medical device companies in the Boston area. It was great to hear about where folks are in the adoption of 62304, and the strategies they are employing to conform in 2011. If you missed this event and you live in the Minneapolis/St. Paul area, there is still time to sign up for the next one. We will be presenting this complementary seminar in downtown Minneapolis at the Marriott on Thursday, January 13. You can learn more and sign up here: Software Development for Medical Devices Managing Software Risk on the Road to FDA Compliance Lunch is included! The only negative of the event was that the elevator in the parking garage was broken so I had to haul a heavy box, plus my laptop/backpack down two flights of cement stairs. Fortunately a kind soul (who also attended the seminar) took pity on me and helped me carry it down. Thankfully, on the way back up the box was much lighter! Our savvy marketing staff here had equipped me with a dolly so it was much easier to drag the stuff back up to my car.