Agile methodology has become increasingly popular in various industries, including medical device development. Ensuring regulatory compliance becomes crucial in this sector. While Agile can certainly support regulated product development, certain Agile practices need to be implemented to maintain compliance.
Dr. Andreas Birk, an expert in Agile processes and the founder of Software.Process.Management, offers valuable insights into the Agile practices that aid regulated development. He proposes a systematic approach for organizations involved in medical device development to establish an Agile quality management system (QMS) and achieve compliance incrementally.
Agile methodology allows for iterative development and continuous improvement so that organizations can respond quickly to regulatory changes. Organizations can adopt specific Agile practices, such as clear documentation and traceability, risk-based prioritization, and frequent communication with regulatory bodies, to ensure regulatory compliance.
While Agile can support regulated product development, implementing the necessary Agile practices is crucial to ensure regulatory compliance. Dr. Birk's proposed approach of building an Agile QMS incrementally provides medical device developers with a structured way to achieve compliance while harnessing the benefits of Agile methodology.