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

Michael Walkden

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 in most instances. However, those who write software that must be reviewed by the FDA know that, at first look, the FDA regulations run counter to this approach. They lend themselves well to a heavyweight waterfall process with big design upfront and heavyweight documentation. How can you gain the benefit of optimizations such as minimal documentation, a lot of verbal communication, rapid feedback loops, collective code ownership, rapidly pivoting the product based on customer development, reduced waste and increases speed of development?

Can you get the benefits of agile in an FDA regulated environment?  Yes. We are doing it right now. I’m going to be talking about how over the next few weeks.

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