Conference Presentations

Implementing Agile in an FDA-regulated Environment

While many industries have adopted agile, the medical device industry, which develops products for life-critical applications-where quality and reliability are clearly a top-priority, remains largely stuck under the “waterfall.” Medical device firms must comply with FDA regulations that overwhelmingly suggest a controlled, phase-gated approach to software development. Unfortunately, many companies and development organizations interpret FDA regulations to require a steep waterfall. Many industry long-timers incorrectly see agile as an undisciplined style of software development. Neeraj Mainkar demonstrates how those in regulated industries can overcome these and other hurdles. At Neuronetics, he helped implement key elements of agile while fully complying with FDA regulations.

Neeraj Mainkar, Neuronetics

AgileConnection is one of the growing communities of the TechWell network.

Featuring fresh, insightful stories, TechWell.com is the place to go for what is happening in software development and delivery.  Join the conversation now!