Customer Requirements Validation Procedure

This procedure provides instruction for conducting a Customer Requirement Validation (CRV) for a new medical device in advance of a full market release to obtain user feedback on a specific product configuration and to determine the marketability of a device.

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Customer Requirements Validation Procedure

This procedure provides instruction for conducting a Customer Requirement Validation (CRV) for a new medical device in advance of a full market release.

Customer Requirements Validation Procedure - Overview

The Customer Requirements Validation Procedure guides medical device design teams in the development of a customer requirements validation plan. The CRV Plan is intended to obtain user feedback in advance of a Full Market Release in order to gauge the effectiveness of the design to meet customer requirements determine the products marketability in the targeted market area.