Medical Device Labeling Procedure Bundle

The Medical Device Labeling Procedure Bundle includes procedures to govern the creation and approval of labels, inclusion of UDI information, establishment of shelf-life claims and requirements for applying a CE Mark to medical device labels.

• MS Word Format

• Digital Content - Instant Download

Medical Device Labeling Procedure Bundle

The Medical Device Labeling Procedure Bundle includes procedures to govern the creation and approval of labels, instruction on unique device identification (UDI) codes, establishment of shelf life claims and CE Marking requirements for medical device labels.

Medical Device Labeling Procedure Bundle - Content

The Medical Device Labeling Procedure Bundle product includes the following procedures:

• Label Review and Approval Procedure -The ISO 13485:2016 Label Review and Approval Procedure defines the process for creating, reviewing, revising and controlling device labeling for use on commercial product for human use.

• Unique Device Identification Procedure -The Unique Device Identification (UDI) Procedure defines the process of creating, submitting and maintaining Unique Device Identification (UDI) codes.

• Product Stability Shelf Life Procedure -The Shelf Life Procedure defines the required testing to support medical device shelf life claims.