Agile hacks for a medical device

Manon Penning, March 2015

Who is afraid of the Big Bad Auditor? Despite success stories of agile development and test automation, and even recognition of the need for exploratory testing by formal agencies like the FDA, they all still tend to creep out the QA people.

How to justify exploratory testing on a medical device, use various levels of automated checks as evidence (including specification by example), and combine all of that into a pragmatic approach? This article describes the journey taken while developing a medical device, which I can assure you is no fairy tale and might contain a useful lesson or two for your own organization.

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