Medical device development requires a clear connection between user and system needs, design outputs, risk controls and verification evidence. Requirements management can help teams organize those relationships and review changes throughout development.
Why this matters
When evidence is created in separate records, it can be difficult to show how a need or risk control is addressed. Trace links make the relevant work easier to find and review, provided that teams maintain them accurately.
A practical approach
- Capture user needs and intended use in a form that can guide design and verification.
A practical example
Connect design requirements with relevant risk controls and design outputs.
What to keep in mind
Define verification methods and acceptance criteria before test execution.
Frequently asked questions
Record results, deviations and approvals against the version tested.
Review change impact on risk, requirements, design and verification evidence.
Further reading
The views in this article are my own. Product capabilities and availability can change; consult current vendor documentation and your organization’s requirements.
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