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Cybersecurity Guidance for Medical Devices
The U.S. FDA released their final guidance for “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices“.
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Scrum in Medical Device Software Development – Three Critical Aspects
Many companies that develop software for medical devices, including for in vitro diagnostic devices and active implantable medical devices, are still struggling transitioning to an Agile software development process. Assuming you know how to develop software for medical device in the waterfall lifecycle model transitioning to an evolutionary (or spiral) lifecycle model does not take […]
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Considerations for a successful implementation of an Agile SDLC for Medical Devices
I was invited to speak about considerations for a successful implementation of an Agile SDLC for Medical Devices at the “Medical Devices Conference™ Tools, Technologies and Strategies to Accelerate Your Time to Market” (http://www.devicestimetomarket.com/) in November 2012. Agile and Lean development methodologies can not only expedite time to market, but also improve quality. With the right customization on […]