Agile methodology has been adapted to the medical device industry to incorporate risk management, human factors and verification and validation so that it satisfies both the letter and the spirit of the FDA’s Quality System Regulation.

Agile methodology is designed to get feedback early and often during the course of product design and use this feedback to continuously improve the product. This fast feedback cycle, coupled with agile practices such as test driven development and continuous integration, allow product organizations to rapidly reduce requirements uncertainty, more closely