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Faster Launch in FDA Regulated Environments Using Agile

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 regulates software for medical devices, and may in future regulate mobile medical software as well. Can you speed up time to market with Agile development in an FDA regulated medical environment? We shared […]

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Agile in FDA Regulated Medical Software - Partnering

FDA

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. This may be generic advice, but it might not be a familiar concept for those in IT working within a large organization doing validated software: Once you adopt the practices described in my previous blogs about regulated software, […]

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Agile in FDA Regulated Medical Software - Sweat the Details

agile, 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. Very few people in the software development community have issues with maintaining good attention to the details. However, I bet those who live in the regulated software community view the “normal” software world as quite […]

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Agile in FDA Regulated Medical Software: Don't Cut Corners

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. I have to thank Tavi Scandiff-Pirvu for coining this expression as it relates to regulated software development. As long as you use industry standard methods, the FDA allows you to determine the rules that you are […]

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Agile in FDA Regulated Medical Software

agile, FDA, medical device software development

Testing is a crucial part of all software development. If you don't believe this you are likely just starting your career or haven't had to support an application in production with users. It becomes

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Agile in FDA Regulated Medical Software - Checklists

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. Let’s be honest: Checklists aren’t the most exciting topic to blog about. However, in the context of regulation, they become interesting. Everybody loves checklists and hates them at the same time. It’s really easy to […]

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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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