Pure Global AI
Free labeling evidence review · No signup

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.

Free · no loginStructured outputPaste up to 50,000 charactersCurrent-source checks when useful

Paste your device profile, target markets, labels and IFU text

Try an example

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 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

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

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.