March 16, 2012

Check Out Our Newest White Paper: Agile in FDA-Regulated Environments


Agile is a set of beliefs that stress flexibility and welcomes change to product requirements throughout the development lifecycle. In contrast, FDA requires concrete documentation to prove that processes were followed, issues addressed, and risks mitigated. Frequent change within that framework might appear to be very risky. Can Agile be used in an FDA-regulated environment?Long story short, yes it is possible to successfully adopt Agile practices in regulated environments if the transformation is treated with insight and caution. In fact, if you read the FDA "Design Control Guidance for Medical Device Manufacturers" publication, you'll notice they actually recommend taking an iterative approach to design and development. Many device manufacturers are already using spiral and iterative Waterfall approaches, rather than a classic Waterfall approach. We're here to help you take that next step, and begin to adopt Agile practices that can further improve quality and improve product fit with end users. In our newest white paper, Agile in FDA-Regulated Environments, we explore the areas that Agile methodologies can be used effectively to speed product development and innovation while  continuing to meet FDA regulations. The paper provides insight into the following areas:

  • How Just in Time (JIT) requirements can reduce documentation needs and actually improve alignment with FDA guidance.
  • Improving agility of the verification and validation phase, and incorporating aspects of that work into every iteration.
  • Ways to improve quality and reduce bug counts at the code level, where finding and fixing issues is cheapest and least risky.

If your team is considering adopting Agile practices, download the paper to get some real-world insight into the challenges and best practices related to the transformation.