Risk Management in Medical Device Software: Frameworks, Tools, and Best Practices for Ensuring Patient Safety

Abstract

This abstract presents a comprehensive review of frameworks, tools, and best practices aimed at managing risks associated with medical device software throughout the product lifecycle. The paper explores key concepts in risk management, including hazard analysis, risk assessment, and risk mitigation strategies, within the context of regulatory requirements such as ISO 14971 and FDA guidelines. Various risk management frameworks and methodologies, such as Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA), are discussed, along with software-specific risk management techniques tailored to the unique challenges of medical device software development. Additionally, the abstract highlights the importance of incorporating risk management into the software development process, from requirements definition to post-market surveillance, and provides recommendations for integrating risk management practices into existing quality management systems. By implementing robust risk management frameworks, leveraging advanced risk assessment tools, and adopting best practices for ensuring patient safety, medical device manufacturers can mitigate risks effectively and enhance the overall quality and reliability of medical device software.