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- ISO 13485 Label Review and Approval Procedure
ISO 13485 Label Review and Approval Procedure
- 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 [email protected]
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Medical Device Labeling Procedure Bundle
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Medical Device Quality Management System | DESIGN PLUS
The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 46 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING
The Medical Device Quality Management System | MANUFACTURING product is designed for companies engaged in both product development and the manufacture of medical devices. The system is rich in content and provides detailed instruction governing research and development, manufacturing and post commercialization activities. The system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 60 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System | MANUFACTURING PLUS
The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
- Quality Management System Manual
- 72 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download