1. Register and apply
Create a verified representative account, identify the legal manufacturer and submit product-level application information.
2. Application review
NOTICE verifies scope, device classification, applicable codes, resources and the proposed assessment route.
3. Agreement and project setup
Following acceptance and contractual completion, controlled work packages, teams and schedules are established.
4. Assessment streams
Product assessment and QMS audit streams are planned and performed with controlled records and NC/CAPA follow-up where required.
5. Independent review and decision
Required streams converge before completeness review and an independent certification decision.
6. Certificate lifecycle
Issue, surveillance, changes, recertification and public verification remain linked to the controlled certification record.
