Integrating Agile practices in Medical Device Hard ware Development

Abstract

This thesis explores the integration of Agile project management practices into medical device hardware development, with a focus on risk mitigation strategies. The purpose was to examine how Agile principles, typically used in software development, can be adapted to meet the strict regulatory and safety requirements of hardware-based medical projects. The research was conducted through a qualitative approach, combining a descriptive literature review with thematic analysis. The study used a mechanical CPR machine development project as a contextual reference to assess practical implementation challenges and benefits. Results demonstrate that Agile methods, when tailored to comply with standards such as ISO 13485 and ISO 14971, can support iterative development, early risk detection, and better alignment between technical teams and regulatory expectations. The findings suggest that Agile can enhance flexibility and efficiency in medical hardware development without compromising compliance or quality.