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AI Medical Device Risk Management File Review
Turn a risk plan, hazard analysis, FMEA, control list and verification evidence into a structured, traceable gap report. The agent distinguishes completed evidence from plans and unsupported assumptions.
Free · no loginStructured outputPaste up to 50,000 charactersCurrent-source checks when useful
Paste your device, risk, control, verification, and post-market evidence
Try an example
Paste a risk-management plan, hazard analysis, FMEA excerpts, risk controls, verification references, residual-risk conclusions, complaints, or a combined evidence pack.
Separate documents with headings when possible. Do not paste patient-identifying information.0 / 50,000
Privacy: Pure Global does not publish this pasted text or generated workpaper. It is processed for this review and sent to our AI provider. Avoid patient-identifying information and confidential material you are not authorized to share.
About this agent
What to paste for a useful review
Include the device scope, intended use, lifecycle, risk criteria and the actual hazard-analysis or FMEA rows you want reviewed.
Add control implementation and verification references, overall residual-risk reasoning, complaints, CAPA and post-market signals.
Review FDA benefit-risk and ISO 14971 recognition resources ↗
- Does this generate an ISO 14971-compliant risk file?
- No. It reviews and structures the text you provide using independent high-level areas. It does not reproduce the standard or replace a licensed copy and qualified review.
- Can I paste an FMEA?
- Yes. Include column headings and representative rows, plus the risk criteria, linked controls and verification references so the agent can assess traceability.
- Will the tool invent severity or probability scores?
- It is instructed not to invent scores. Missing or unsupported values should be identified as questions or evidence gaps.
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