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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 Guide – The Ultimate Definition
On September 24, 2014 Scrum Inc., Scrum.org, and the Scrum Alliance agreed on The Scrum Guide as the ultimate definition of Scrum.
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Using Scrum to Improve your Everyday Time Management
Scrum is a framework that’s mostly known for its use in Agile software development. In this article I show an approach how to use some of the ideas behind Scrum to manage your everyday activities and tasks, no matter if they are related to product development or not, no matter if they are work related…
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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…