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="Kevin"]telling them they are the ones who have to change does not go over very well [/quote] You're right that you can't just tell them to go away -- you need to work with them to show how the practices comply with the objectives. While there are some regulators who adopt...

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 documents I have needed to read...

Kevin, Your proposal is a good start - basically you're describing a stage-delivery lifecycle. But, I suggest you really question the assumption that "FDA desire to have all the requirements and hazards detailed before design." We've worked with many companies that had perceived restrictions...

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...