Medical-Device Evidence Checklist for an Initial Project Review

Last reviewed: 2026-10-03

Start an initial medical-device review with the product and the decision the evidence needs to support. A useful checklist identifies available information and gaps; it does not mean every device requires every test family listed below.

Define the device and market

Describe intended use, users, technology, variants, accessories and target countries. Provide the classification rationale if available and identify the manufacturer and relevant sites. Explain whether the project is early development, a new market entry or remediation of an existing submission.

Organise existing workstreams

Group available QMS and risk-management information; electrical and EMC reports where relevant; material and patient-contact evidence; software or cybersecurity evidence where applicable; packaging and sterilisation documentation; performance or clinical evidence; and labelling and post-market information. Note which items have not been evaluated for the current configuration.

Check configuration and acceptance

A report should be traceable to the model and conditions assessed. Ask whether the laboratory scope and report are suitable for the intended regulatory use. Resolve those questions before commissioning repeat work or assuming previous evidence can be reused.

ConformArc can coordinate an agreed evidence plan and independent testing engagement. Use Medical Device Testing, ISO 13485 readiness, or Request Review to outline the project. Do not upload patient records or confidential technical files to the initial form.