Prepare source documents before upload

Before upload, gather documents that describe the device, intended users, indications, contraindications, patient-contacting materials, software behavior, manufacturing controls, risk controls, clinical evidence, verification, labels, IFU, and PMS processes.

Use clear file names such as “IFU-PB560-v3.pdf” or “Risk-Management-File-2026-01.docx”. Good names help your expert understand provenance and reduce the chance that evidence is interpreted out of context.

Do not upload passwords, private keys, or unrelated personal data. If a document includes sensitive information that is not relevant to the case, consider redacting it before upload while preserving the regulatory evidence needed for review.