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.
Free risk-management workpaper · No signup
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.
Paste up to 50,000 charactersEvidence-first agent workflowBranded A4 report
Inventory risk evidence
The agent separates supplied facts, documents, assumptions and unknowns.
Review traceability and controls
Every finding stays tied to the evidence you actually supplied.
Download a prioritized workpaper
Turn the result into a practical worklist and save it as a branded PDF.
Review and structure your risk management file
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 save this pasted text or the generated report. The text is sent to our AI provider for this one-time analysis. Avoid confidential information you are not authorized to share.
DJ Fang
MedTech Regulatory Expert
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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.
Continue your regulatory workflow
Move from this workpaper into the next connected review. Pasted evidence stays on this page and is never placed in a link.
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Frequently asked questions
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.
Is my text stored?
Pure Global does not save the pasted text or generated report. It is sent to the AI provider for this one-time review.