Traceability matrix for medical devices
What a requirements traceability matrix looks like for a medical device, from user needs through requirements and risk controls to verification, and how to keep it honest between audits.
The full chain
For a medical device, the traceability matrix covers more than requirements to tests. It traces the full chain: user needs down to design inputs and requirements, requirements across to the risk controls that address hazards, and requirements down to the verification and validation that confirm them. A reviewer expects to follow any link in that chain, in either direction.
Why it matters for audits
The matrix is the fastest way to demonstrate coverage: that every requirement is verified, every user need is satisfied, and every identified hazard has a control that traces to a requirement and a test. A gap in the matrix is a gap in the evidence, and it is exactly what an auditor looks for.
Keeping it current
A hand-maintained matrix is out of date the moment a requirement changes. Generating it from live trace links keeps it accurate and surfaces broken traces, so coverage is honest between audits, not reconstructed before one. See how Traceable does this in the requirements traceability matrix, start from the template, or see the wider medical device solution.
This guide is educational and does not certify any product or organisation.
Common questions
What does a medical device traceability matrix trace?
It traces the full chain: user needs to design inputs and requirements, requirements to risk controls, and requirements to the verification and validation that confirm them. Reviewers expect to follow any link in that chain in either direction.
Why do auditors care about the traceability matrix?
It is the fastest way to show coverage: that every requirement is verified, every user need is met, and every hazard is controlled. Gaps in the matrix are gaps in the evidence.
How do I keep it current?
Generate it from live trace links rather than maintaining it by hand. That way it reflects the current state and flags broken traces instead of drifting between audits.
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