ISO 13485 Label Review and Approval Procedure
SKU:
SOP 7-027
$149.00
$149.00
The ISO 13485 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).
- ISO 13485:2016 Compliant
- 21 CFR Part 820 Compliant
- 21 CFR Part 801 Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Instant Download Digital Content
ISO 13485 Label Review and Approval ProcedureThe 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 OverviewThe 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. Label Review and Approval Procedure ComplianceThe Label Review and Approval Procedure is ISO 13485:2016 and FDA 21 CFR Part 820 compliant.
For more information about our ISO 13485 Label Review and Approval Procedure contact us at info@aplyon.com
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