Questions, answered

Click Get started, then use Proto to configure QMS for Medical Devices for your business. Pilot one incoming or final inspection with its requirement checks, evidence and reviewer decision before adding more quality work.

The inspection type can be Incoming, in process, Final or Service. Each inspection has a subject reference, schedule, assigned person and status.

Inspection checks sit beneath an inspection. Each check records a requirement, observation, result and optional evidence attachment.

The Quality Reviewer examines an inspection in Review and accepts passing scope or rejects failed scope. A rejected case can raise a linked nonconformance.

The nonconformance keeps the inspection link, severity and description. A corrective action connects to that issue and retains its owner, root cause, action and due date. Effectiveness is reviewed before the action closes.

A device history review records the device lot, identifier, record package, review date and linked operational inspection. The review moves through pending and incomplete work before approval.

A supplier certificate keeps the supplier, component code, certificate type, expiry date and attachment beside its linked inspection. The inspector submits it with the operational case for review.

A training acknowledgment links a person and acknowledgment date to a controlled document. The document carries its title, version, effective date, file and status.

Each finding links to an audit and records its requirement, description, severity, due date, closed date and owner. The audit holds its scope, auditor and progress status.

Agree on a stable subject reference for each inspection and test it with one representative case. The integration guide describes the handoff.