Customer Requirements Validation Procedure

Use this editable Customer Requirements Validation (CRV) Procedure to plan user feedback on a defined medical device configuration before full market release and assess how well it meets customer needs.

The procedure guides preparation of a CRV plan, collection of feedback and review of evidence relevant to product configuration, customer requirements and market readiness.

Testing the customer need

Customer Requirements Validation (CRV) connects the proposed device and its design outputs to the needs of the intended customer and user. The project team plans the evaluation, gathers objective feedback and assesses whether the product concept, performance and use expectations are met.

Decision and follow-up

Management and product leadership review the CRV evidence and any unresolved issues before a commercial-release decision. Field and post-market information can feed back into the validation record and future changes.

Supplied as an editable Microsoft Word document as a digital download.

Related design evidence

Define measurable requirements with the Product Performance Specification (P-Spec) Procedure. For planned design verification and validation records, see the separately sold Design Verification and Validation Procedure.