Posts Tagged ‘FDA Software Validation’

  • 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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  • Developing Software for Medical Devices – Interview with SterlingTech

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

    meddevice2

    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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