According to IEC 62304, medical device manufacturers should strive to implement a risk-based, structured, and methodical approach to medical device software development and ensure traceability throughout the lifecycle of medical device software to achieve compliance with the standard.
Medical device manufacturers should take advantage of modern requirements management tools, which help ensure requirements are being met by offering end-to-end traceability and the ability to link functional requirements to test cases, design specs, and other artifacts.
The ability to describe and follow the life of a requirement in both a forward and backward direction provided by a capable requirements management tool allows medical device manufacturers to accelerate product development and improve the overall quality of medical devices.
One requirement management tool that is particularly capable of meeting the needs of the medical industry is Visure Requirements ALM. This highly collaborative and feature-rich ALM platform provides full traceability and offers high integration with MS Word and Excel, bug tracking, and risk management features, among many others.
Visure Requirements improves efficiency in an environment of constant competition like the medical industry, reducing costs while helping ensure successful software development by defining requirements, specifications, test and risk, and traceability between them.