While Requirements Traceability Matrix (RTM) is mandatory for the design process, it also has its own set of challenges.
If a medical device manufacturer is using a paper-based system to create Requirements Traceability Matrix, they need more tools to improve traceability among teams.
As multiple people have access to the same Requirements Traceability Matrix document, there is a risk of tampering.
In a large-scale setup, traceability increases efforts.
Without the right set of tools, understanding the Requirements Traceability Matrix (RTM) can become a tedious and time-consuming process for teams.
Moving away from a manual RTM can help resolve many of the challenges. With ComplianceQuest’s Requirements Traceability and Product Risk solution, medical device manufacturers can create a living design file that improves teams’ collaboration, version control, traceability, and compliance.