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.

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Supplied as one editable Microsoft Word document in a digital download.

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.

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.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Usability and Customer Requirements Validation for workflow guidance, a checklist and common mistakes.