regulated environments

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
Solid Software: Is it Rocket Science?

While we can't guarantee that our software will never fail, we can take serious steps to reduce the risk. The toughest kind of system to build involves safety-critical software where the reliability requirements are extremely strict-and whose failure puts lives in jeopardy. Shari Lawrence Pfleeger looks at what "solid software" means, and explores ways we can achieve it. She examines solid software within the context of the proposed National Missile Defense System.

Shari Lawrence Pfleeger, Systems/Software, Inc.

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