Prepare IFU and label source inputs

Upload current labels, IFU, packaging artwork, symbol explanations, warnings, contraindications, storage conditions, sterile status, single-use information, and any market-specific language versions.

Label and IFU claims must align with the intended purpose, clinical evidence, risk controls, and device description. If claims drift beyond the evidence, the expert may flag them for revision.

Where language versions are planned but not ready, identify the intended markets and translation status. This helps separate technical content review from localization readiness.