Set Up an Agile Quality Management System for Regulatory Compliance

A guide for establishing an Agile quality management system in medtech that meets regulatory compliance requirements, streamlines development processes, and improves efficiency.

Practical information on methods and strategies to implement Agile successfully in safety-critical product delivery 

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. 

Agile Best Practices for Medical Device Development

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