Beauty Device Evidence File: IFU, Training and Claims Review

Connect the evidence chain

Keep the exact model, IFU version, training record, maintenance file and copy-review decision together. A brand name alone is not enough to establish the intended use of a specific configuration.

Review claims in context

Do not turn a listing, training certificate or manufacturer document into a blanket safety or outcome guarantee. Escalate medical-use or high-risk claims for appropriate review.