Posts Tagged ‘Medical Device Software’

  • Is Pure Agile Always an Option?

    on Oct 4, 11 • by Todd Landry • with 2 Comments

    Even industries heavy on process (because of regulatory requirements) are taking the leap into agile. How agile are they?

    Over the past few years I’ve talked to a number of customers in the embedded software and medical devices industries, and I continue to see a significant number of these organizations either moving to, or planning on moving to agile development processes. With all of the inherent challenges for agile in these organizations such as standards/regulatory compliance, hardware changes and integration, security issues, etc. I must say that I’m a little shocked that customers are moving away from their current processes towards something like agile. Add to this the fact that the Agile Manifesto specifically

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  • Medical Devices Roadshow – Minneapolis style

    on Jan 14, 11 • by Todd Landry • with 2 Comments


    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


    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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  • Software Tool Validation for the FDA

    on Sep 14, 10 • by Brendan Harrison • with No Comments

    Open source and medical devices

    We get many questions from medical devices customers on how they should validate the use of Klocwork’s static analysis tools for the FDA. I suspect the situation would be similar for most vendors of software development tools. As we’ve done before, we thought it would be a good idea to ask Bruce Swope from SterlingTech Software to clarify this whole topic for us. [Brendan] First, what is tool validation? [Bruce] Tool validation is the act of demonstrating that a tool will consistently produce expected results. [Brendan] How can a medical device company know whether they

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  • IEC 62304 – The Basics

    on Sep 9, 10 • by Brendan Harrison • with 2 Comments

    MRI Software

    IEC 62304 is becoming a hot topic amongst medical device software professionals. We asked Bruce Swope, VP Engineering at SterlingTech Software for his views on this standard and what it all means for medical device companies. Bruce has extensive experience in medical device software development and he is an expert in leading Class III medical software products to commercial release. His depth of experience also spans the development of enterprise solutions, security applications, internal applications, and process control systems. He has been an early adopter of quality practices including ISO 9000 processes, Common Criteria Certification

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  • Developing Software for Medical Devices – Interview with SterlingTech

    on Jan 5, 10 • by Brendan Harrison • with 9 Comments


    I had a chance to speak with Bruce Swope, the VP of Engineering at SterlingTech, an ISO13485 Registered full-service medical device software organization offering software development and validation services. SterlingTech has developed software for an array of medical products including implantable devices as well as external support and monitoring equipment. Their team has worked on Class I, II, and III devices that resulted in successful FDA 510(k)s, PMAs, and CE submissions. Bruce has extensive experience in medical device software development and he is an expert in leading Class III medical software products to commercial release. His depth

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