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          • Process Validation Procedure
          • Validation Protocols - Reports Procedure
          • Process Risk Management Procedure
          • Device History Record
          • Identification Procedure
          • Lot Inspection Procedure
          • First Article Inspection Procedure
          • Line Clearance Procedure
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        • Internal Audit Procedure
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  • ISO 13485 Label Review and Approval Procedure

ISO 13485 Label Review and Approval Procedure

SKU: SOP 7-027
$149.00
$149.00
Unavailable
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
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ISO 13485 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.

Label Review and Approval Procedure Compliance

The 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 ​

RELATED LINKS

​Medical Device Quality Systems
​Medical Device Labeling Procedure Bundle
​CE Marking Procedure

Shelf Life Procedure
​Unique Device Identification Procedure
​Engineering Change Notice 
ISO 13485 Label Review and Approval
Label Review and Approval Procedure

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Medical Device Labeling Procedure Bundle

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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.
  • ISO 13485:2016 Compliant
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Unique Device Identification Procedure

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The Unique Device Identification (UDI) Procedure governs the process of creating, submitting and maintaining Unique Device Identification (UDI) codes for the FDA GUDID system. The UDI procedure meets FDA Issuing Agency GS1 standards and the requirements of 21 CFR Part 830.
  • ISO 13485:2016 Compliant
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CE Marking Procedure

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The CE Marking procedure governs the content of CE Technical Files and Design Dossier's. The CE Marking Procedure also provides instruction on device classification in accordance with Medical Device Regulation MDR (EU) 2017/745. 
  • ​ MDR EU 2017/745 Compliant
  •  ISO 13485:2016 Compliant
  • ​ MEDDEV 2.4.1 Compliant
  •  MS Word Format
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  • HOME
  • STORE
    • ISO 13485 QUALITY SYSTEMS >
      • MANUFACTURING PLUS
      • MANUFACTURING SYSTEM
      • DESIGN PLUS SYSTEM
      • DESIGN SYSTEM
      • BASE PLUS SYSTEM
      • BASE SYSTEM
      • ISO 13485 Quality Management System Manual
    • ISO 13485 PROCEDURE BUNDLES >
      • ISO 13485 Document Control Procedure Bundle
      • Design Control Procedures Bundle
      • Risk Management Procedures Bundle
      • Medical Device Labeling Bundle
      • Medical Device Software Procedure Bundle
      • Clinical Evaluation Procedure Bundle
      • Cleanroom Procedure Bundle
      • Complaint Handling Procedures Bundle
    • ISO 13485 QUALITY SYSTEM PROCEDURES >
      • ISO 13485 DOCUMENTATION REQUIREMENTS PROCEDURES >
        • Engineering Change Notice Procedure
        • Document Control Procedure
      • ISO 13485 MANAGEMENT RESPONSIBILITIES PROCEDURES >
        • Management Review Procedure
      • ISO 13485 RESOURCE MANAGEMENT PROCEDURES >
        • Training Procedure
        • Facility Inspection Procedure
        • Respiratory Protection Procedure
        • Biohazard Procedure
        • Lockout - Tagout Procedure
        • Preventive Maintenance Procedure
      • ISO 13485 PRODUCT REALIZATION PROCEDURES >
        • ISO 13485 DESIGN - DEVELOPMENT PROCEDURES >
          • Design Control Procedure
          • Customer Requirements Validation
          • Human Factors - Usability Engineering Procedure
          • Design Review Procedure
          • Risk Management Procedure
          • Design Transfer Procedure
          • Shelf Life Procedure
          • Technology Transfer Procedure
          • Design Verification - Validation Procedure
          • Design Risk Management Procedure
          • Design Analysis Procedure
          • Biocompatibility - Toxicity Testing Procedure
          • ISO 13485 Label Review and Approval Procedure
          • Unique Device Identification Procedure
          • Software Development Procedure
          • Software Clinical Evaluation Procedure
          • Clinical Evaluation Procedure
          • Clinical Investigation Procedure
          • CE Marking Procedure
        • ISO 13485 PURCHASING PROCEDURES >
          • Supplier Management Procedure
        • ISO 13485 PRODUCTION - SERVICE PROVISION PROCEDURES >
          • Cleanroom Design and Validation Procedure
          • Environmental Controls Procedure
          • Controlled Environment Cleaning Procedure
          • Sterile Load Preparation - Release Procedure
          • Gamma Irradiation Sterilization Validation Procedure
          • Ethylene Oxide EO Sterilization Validation Procedure
          • Software Validation Procedure
          • Installation Qualification (IQ) Procedure
          • Process Validation Procedure
          • Validation Protocols - Reports Procedure
          • Process Risk Management Procedure
          • Device History Record
          • Identification Procedure
          • Lot Inspection Procedure
          • First Article Inspection Procedure
          • Line Clearance Procedure
          • ISO 13485 Contract Review Procedure
        • ISO 13485 CONTROL MONITORING MEASUREMENT DEVICES PROCEDURES >
          • Calibration System Procedure
      • ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT >
        • Complaint Handling Procedure
        • Complaint Trending Procedure
        • Nonconforming Material Procedure
        • Corrective - Preventive Action Procedure
        • Internal Audit Procedure
        • Medical Device Report MDR Procedure
        • Product Hold Procedure
        • Remedial Action - Recall Procedure
        • Statistical Techniques Procedure
        • Post Market Surveillance Procedure
        • Periodic Safety Update Report (PSUR) Procedure
        • Vigilance Procedure
        • Failure Investigation Procedure
    • VALIDATION PROTOCOLS >
      • Ethylene Oxide (EO) Product Adoption
      • Accelerated Aging Study
      • Injection Mold Validation Procedure
      • Final Cleaning Orthopedic Implants
      • Bar Sealer Operational Qualification OQ Protocol
      • Bar Sealer Performance Qualification PQ Protocol
      • Bar Sealer Qualification Protocol Bundle OQ - PQ
      • Tray Sealer Operational Qualification OQ Protocol
      • Tray Sealer Performance Qualification PQ Protocol
      • Tray Sealer Qualification Protocol Bundle OQ - PQ
      • 4 Sided Sealer Operational Qualification OQ Protocol
      • 4 Sided Sealer 4SS Performance Qualification PQ Protocol
      • 4 Sided Sealer Qualification Protocol Bundle OQ - PQ
    • CONTRACTS - AGREEMENTS >
      • Medical Device Quality Agreement | US
      • Medical Device Quality Agreement | EU
      • Master Consulting Agreement
  • CONSULTING
    • QUALITY SYSTEM INSTALLATION - TRAINING
    • FDA QSIT AUDIT PREPARATION
    • DESIGN - PROCESS VALIDATION
  • FDA US AGENTS
    • US AGENTS
    • FACILITY REGISTRATION SERVICES
    • FDA FURLS DATABASE DATA ENTRY SERVICES
  • ABOUT
  • CONTACT
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