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AI Medical Device Label & IFU Review

Review carton labels, device labels and instructions for use as one controlled information set. The agent identifies internal inconsistencies, missing evidence and market-specific questions without pretending to approve artwork.

Paste up to 50,000 charactersEvidence-first agent workflowBranded A4 report

Compare labels and IFU

The agent separates supplied facts, documents, assumptions and unknowns.

Find safety and traceability gaps

Every finding stays tied to the evidence you actually supplied.

Review named target markets

Turn the result into a practical worklist and save it as a branded PDF.

Review your medical device label and IFU

Include the intended purpose, user, device class or product code if known, target markets, carton/device labels, IFU excerpts, symbols, UDI status, claims and revision information.

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
DJ Fang
MedTech Regulatory Expert

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Pricing

What to paste for a useful review

State the device, intended use, users, environment, prescription/OTC status if known and every target market.

Paste all visible label text, IFU sections, symbol glossary, UDI status, claims and artwork/revision notes. State whether the paste is complete or only a sample.

Review FDA Device Labeling

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.

Frequently asked questions

Can I paste only my carton label?

Yes, but areas dependent on the device label or IFU will be not assessed. Labeling should ultimately be reviewed as a consistent set.

Does it support FDA and EU labeling?

Name the target markets in your paste. The tool can screen high-level areas but will identify current official requirements that still require confirmation.

Can it check an image or PDF?

This free version reviews pasted text. Copy the visible text and describe layout elements that affect prominence or grouping.

Does it approve promotional claims?

No. It can flag claim-evidence inconsistencies in the supplied text, but final labeling and promotional review remains the manufacturer’s responsibility.