Writing safety critical software using an agile, risk-based, approach should be the norm in modern medical device development

I first started using and mentoring developers on agile software development techniques like eXtreme Programming (XP) and Scrum over a decade ago. Often called “lightweight” methodologies, agile software development lifecycles have been generally misunderstood as lacking enough rigor and sophistication to be used in safety-critical systems. Many have erroneously assumed that Agile, Scrum, and related methodologies can’t really be implemented in risk- focused “important” industries like medical devices because they believe only classic waterfall will be accepted by the FDA.
Source: The Healthcare IT Guy - Category: Information Technology Source Type: blogs