Karen,
There are a few programs out there - I do not know how well they lend specific to your software but I have seen other medical device companies use them and slightly tailor them to their needs. These are programs like Jira, On-Time, Agile, though many of them are "project management" programs or bug tracker software, but they do lend themselves to tracking requirements of software. Usually many of them take a bit of understanding to get them working correctly for you.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Apr-2020 15:54
From: Karen Zhou
Subject: Traceability of requirements - tools
Hi everyone,
Does anyone know of any software that does a good job of traceability between user needs, design requirements and verification? In particular, is there a standalone software tool that can do this other than Greenlight Guru? We are putting together the design requirements for a medical device (hardware containing software) that has multiple subsystems. What is the best way to define design inputs for a complex device such as this?
Thank you. I would appreciate your input.
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Karen Zhou
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