Software Best Practices

Kevin, [quote user="Kevin"] I am sticking with my original thought (for now), that requirements definition be comprehensive and implementation be iterative. I would love to find compelling arguments to change my mind, but haven't come across them yet. [/quote] I have never been in an environment...

[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...

Hi Susan, I think Bob was more concerned about the business risk that the FDA would not accept the process than the product or project risk that is associated with waterfall type development. The issue is that, as I understand it from my regulated clients, is that you are supposed to define what you...

[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...