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.
Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.