Software Best Practices

[quote user="Earl Beede"]The questions I really think for agile and FDA is more along the lines of how much do we need to define it . I believe my FDA regulated clients define way too much. I could go more with a Gilb EVO approach (the first agile lifecycle?) that has a sharp but small requirements...

[quote user="susan"] Thank you for bringing this up. I, too, work with medical devices and have found it very hard to get people to change from a waterfall process, even when that process is failing miserably. I often hear the excuse - "the FDA won't allow it". But in the FDA...

I would very much like to introduce some Agile practices but work nearly exclusively in the medical device area. By way of explanation for today's post, a project I managed just finished its initial FDA on-site inspection. And let me tell you, those vinyl gloves can get into some pretty sensitive...