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Agile in FDA Regulated Medical Software - Have Some Class

FDA, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. The FDA states that a medical device is a product that is used for medical purposes in patients, in diagnosis, therapy, or surgery. As opposed to pharmaceuticals, who use the body’s metabolism, medical devices act mechanically […]

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Agile In FDA Regulated Medical Software - Methodology

FDA

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. “The analysis of the principles of methods, rules, and postulates employed by a discipline” For software companies these days it seems that it’s not a hard choice to follow Agile principles. With some practice, or […]

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Agile In FDA Regulated Medical Software - It can be done!

FDA, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. We have all heard that developing software utilizing Agile principles yields high quality, working software in customers’ hands quickly. It is widely believed that utilizing Agile practices leads to better, cheaper software than waterfall methods […]

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Agile for FDA Medical Software Seminar

FDA, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Agile emphasizes minimal documentation, a lot of verbal communication and rapid feedback loops to increase software quality, reduce waste and speed development. FDA regulations run counter to this approach, implying a heavyweight waterfall process with […]

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