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  • Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant

Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant

SKU: SOP 8-001
$149.00
$149.00
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The ISO 13485 Complaint Handling Procedure governs the process for receiving, reporting, investigating, documenting and closing medical device complaints. 
  • Comprehensive Complaint Data Capture Form
  • Includes Decision Trees (FDA MDR, Canadian, European)
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • ​MDR EU 2017/745 Compliant
  • MS Word Format
  • Digital Content - Instant Download


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Complaint Handling Procedure

The Complaint Handling Procedure governs the process for receiving, reporting, investigating, documenting, and closing medical device complaints. 

Complaint Handling Procedure - Overview

​The ISO 13485 Complaint Handling Procedure provides instruction on sources of complaints, how to receive complaints into the system, required complaint information, complaint investigations, complaint closure and the establishment of complaint files.

The Complaint Handling Procedure incudes complaint reporting decision trees. The Complaint Handling Procedure includes FDA MDR, Vigilance, and Canadian reporting decision trees.

Complaint Handling Procedure - Compliance

The ISO 13485 Complaint Handling Procedure is FDA QSR, MDR EU 2017/745 and ISO 13485:2016 compliant.
To learn more about our ISO 13485 Complaint Handling Procedure contact us at info@aplyon.com 

RELATED LINKS

​Complaint Handling Procedure Bundle
​Complaint Trending Procedure
​Medical Device Report Procedure
Vigilance Procedure

​
Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
ISO 13485 Complaint Handling Procedure
Complaint Handling Procedure

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Complaint Trending Procedure | ISO 13485 | FDA QSR Compliant

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The Complaint Trending Procedure defines the process utilized to analyze trends in complaint data, describes statistical techniques that can be used during data analysis, and provides instruction on the establishment of alert and action limits to the complaint handling process.

  • ISO 13485:2016 Compliant
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Medical Device Report MDR Procedure | FDA QSR Compliant

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The FDA Medical Device Report (MDR) Procedure describes the process used to create and submit Medical Device Reports (MDRs) to the FDA. The medical device report procedure applies to all devices marketed in the United States unless excluded by FDA regulations.
  • 21 CFR Part 803 Compliant
  • ​21 CFR Part 820 Compliant
  • ISO 13485:2016 Compliant
  • Includes Related Forms
  • MS Word Format
  • Digital Content - Instant Download
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Vigilance Procedure

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The Vigilance Procedure provides instruction on classifying incidents to determine reportability and instruction on overall reporting process.  The Vigilance Procedure Includes a Vigilance Decision Tree. ​
  • ​ISO 13485:2016 Compliant
  • MDR EU 2017/745 Compliant
  • MS Word Format
  • ​Instant Download Digital Content
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Medical Device Quality Management System | MANUFACTURING PLUS

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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 ​
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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
      • ISO 13485 Process Validation Procedure Bundle
      • Medical Device Sterilization Procedure 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
        • Record Retention 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
          • Product Performance Specification Procedure
          • CE Marking Procedure
        • ISO 13485 PURCHASING PROCEDURES >
          • Supplier Management Procedure
          • Purchase Order 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
          • Medical Device Process Validation
          • 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
        • Post Market Clinical Follow Up Plan
        • Post Market Clinical Follow Up Evaluation Report
        • Periodic Safety Update Report (PSUR) Procedure
        • Vigilance Procedure
        • Failure Investigation Procedure
    • VALIDATION PROTOCOLS >
      • Clinical Investigation Report
      • Clinical Investigation Plan
      • Ethylene Oxide (EO) Product Adoption
      • Accelerated Aging Study
      • Injection Mold Validation Procedure
      • Medical Device Software Development Plan
      • 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
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