Start a case from the client dashboard and enter the device name, regulation, intended purpose, and any known classification details. If you are unsure about the class, choose the uncertain option and let the expert review the facts later.
Upload useful source documents as early as possible: IFU, labels, risk files, clinical evidence, design descriptions, test reports, and prior regulatory material. The better the evidence base, the fewer assumptions the drafting workflow has to flag.
A case can begin before every document is available. Missing manufacturer-only details will appear as gap requests, so you can provide them in a structured way and keep the response in the case audit trail.
Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.