Agile Development for FDA Regulated Software

Conventional wisdom holds that the FDA prefers to see medical device manufacturers use a sequential, waterfall lifecycle for product and software development. The result has led many companies to bend and twist the process they actually use so that it looks like a linear process to their regulators. No one is fooled and these efforts mainly add overhead and waste. More importantly, they do little to improve the safety and effectiveness of their products. A growing number of medical device companies are adopting, and adapting, agile principles and practices for the development of regulated software; not just to improve . . .