Implementing Reliability Testing in Medical Device Development
Salonen, Peetu (2024)
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-2024102626850
https://urn.fi/URN:NBN:fi:amk-2024102626850
Tiivistelmä
In the evolving field of medical device development, it is essential to ensure the reliability and safety of products. This thesis presents a reliability testing process tailored for medical devices, integrating agile methodologies and Continuous Integration and Continuous Delivery (CI/CD) practices. The study examines the importance of early integration of testing and risk-based approaches, highlighting the challenges in regulated environments.
A literature review explores current trends in medical device reliability testing, emphasizing the need for efficient testing frameworks. The software testing standard – ISO 29119 – is examined to identify the industry best practices.
After best practices from literature review and testing standards are identified, the reliability testing process is detailed. It includes planning, development and execution stages. Key methodologies include the use of automation and tools such as Robot Framework and Python for keyword-driven testing, Docker for consistent test environments, and Jenkins and Grafana for continuous monitoring and real-time data visualization. The process focuses on iterative approach with continuous adjustments and modular documentation strategies to reduce overhead while maintaining regulatory compliance. The examples demonstrate how modern reliability testing process is effectively implemented into medical device development in modern fast-paced development environments, helping to ensure product safety and compliance.
A literature review explores current trends in medical device reliability testing, emphasizing the need for efficient testing frameworks. The software testing standard – ISO 29119 – is examined to identify the industry best practices.
After best practices from literature review and testing standards are identified, the reliability testing process is detailed. It includes planning, development and execution stages. Key methodologies include the use of automation and tools such as Robot Framework and Python for keyword-driven testing, Docker for consistent test environments, and Jenkins and Grafana for continuous monitoring and real-time data visualization. The process focuses on iterative approach with continuous adjustments and modular documentation strategies to reduce overhead while maintaining regulatory compliance. The examples demonstrate how modern reliability testing process is effectively implemented into medical device development in modern fast-paced development environments, helping to ensure product safety and compliance.