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