As part of a series on High Assurance Agile Development in Regulated Environments is the article
Agile Software Development in Regulated Environments Example: Medical Devices. The purpose of this article and future posts is to introduce the FDA regulatory landscape and then
... see what we can do to “agilify” our practices under these standards as we move forward.
It's been three years since I wrote Agile development in a FDA regulated setting. I'll be interested to see if the application of "agile, high assurance activities" in this environment -- and the associated issues -- have changed since then.
UPDATE (10/23/10): Can and should agile be used for medical device development? Absolutely!
UPDATE (11/27/10): More discussion here: Can Agile Software Methods be used in medical device software development?
UPDATE (11/28/10): Agile Medical Device Software Development?
UPDATE (12/17/10): GE Healthcare Goes Agile
UPDATE (1/5/11): Missed this one: Four Reasons Medical Device Companies Need Agile Development
Bob,
We’re doing IV infusion pump development using agile practices, mostly XP. I’ve got a pre-IDE meeting with FDA in November to discuss. Initial feedback has been positive.
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