Agile hacks for a medical device

Manon Penning
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Agile testing Day NL, March 2015

Who is afraid of the Big Bad Auditor? A likely answer is: Your company’s QA department. Do they have reason to be? Yes of course, there is much at stake! Try combining that somewhat traditional and risk-averse lot with a bunch of creative software guys that have adopted an agile way of working. And as you wander about in your colourful riding hood with a basket full of testing experience in hand, you have found yourself a challenge...

Despite things like FDA recognition for the need for Exploratory Testing of medical devices and success stories of agile development and test automation, they all still tend to creep out the QA people. So there is some huffing and puffing while writing formal plans and even though those plans are stripped to the bone, nothing gets blown away by QA. This is followed by creative testing and in the end you have something in your hands that looks a lot like working software. Will that be enough, or are you eaten after all?

Want to know more about my adventures walking off the beaten track? They entail justifying Exploratory Testing on a medical device, using various levels of automated checks as evidence (including specification by example) and combine into a pragmatic approach that might be usefull for your project.