ISO 13485 Label Review and Approval Procedure

The ISO 13485:2016 Label Review and Approval Procedure establishes a process for creating, reviewing, revising and controlling medical device labeling for all finished devices and their respective packaging and Instructions For Use (IFU).

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ISO 13485:2016 Label Review and Approval Procedure

The Label Review and Approval Procedure defines the process for creating, reviewing, revising and controlling device labeling for use on commercial product for human use.

Label Review and Approval Procedure Overview

The Label Review and Approval Procedure applies to all finished devices and their respective labeling. The Label Review and Approval Procedure includes detailed label content review for unit, box, shipper labels and approval forms. The Label Review and Approval Procedure also includes detailed IFU content and review form that is made part of the review and approval cycle.