Being agile while still being compliant
KeithCollyer 270001D2S4 Visits (1544)
I have recently co-authored a developerWorks article with Jordi Manzano of Diagnostic Grifols covering how you can adopt agile approaches within a highly regulated environment. Although the article is about how agile development practices can be adopted in the medical device field, the approach can be easily adopted by organizations working in other regulated fields.
In general, medical device regulations do not enforce a fixed development lifecycle, but development activities are often presented as if they have to be followed sequentially, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Indeed, several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts between the approaches arise and decisions have to be taken in favor of agility or formality. The Association for the Advancement of Medical Instrumentation (AAMI) has produced a new Technical Information Report, TIR45, that gives guidance on the use of agile practices in medical device development. This report (Medical device software - Software life cycle processes) adds new insights on the subject by mapping IEC 62304 activities into the agile development process.
In the article, we describe:
Diagnostic Grifols recently underwent a major United States Food and Drug Administration (FDA) audit and passed with no major issues raised. The audit covered software that Diagnostic Grifols developed using agile approaches as described in the article.
You can find the article here.