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  • Medical Device Quality Agreement for US

Medical Device Quality Agreement for US

SKU: QA-US
$119.00
$119.00
Unavailable
per item
The Medical Device Quality Agreement for US defines the individual responsibilities of the parties as to the regulatory and quality aspects of a medical device intended for distribution in the United States.  The Quality Agreement is intended to be used to define the division of responsibilities between the parties and to demonstrate their compliance with applicable regulatory requirements of the United States Food and Drug Administration (FDA).​
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Medical Device Quality Agreement for US

The Medical Device Quality Agreement for US defines the individual responsibilities of the parties as to the regulatory and quality aspects of a medical device intended for distribution in the United States.

Medical Device Quality Agreement Overview

The Medical Device Quality Agreement for US defines the responsibilities of the "Supplier" and "Company" for the following subject matter:
  • Regulatory Clearances and Approvals
  • Medical Device Labeling
  • ​Quality System Requirements (each QMS element)
  • Complaint Handling and Reporting
  • ​Corrections and Removals
  • FDA Registration and Listing
  • ​Amendments to Agreement
​The Quality Agreement includes detailed table of responsibilities to clearly define both parties responsibilities to ensure a proper "meeting of the minds" and clarity as to each parties role for each defined topic.

Medical Device Quality Agreement Compliance

The Medical Device Quality Agreement for US complies with FDA Requirements for Supplier Management including FDA QSR.
For more information regarding our Medical Device Quality Agreement contact us at info@aplyon.com
​

RELATED LINKS

Medical Device Quality Agreement for Europe
​Master Consulting Agreement
​Supplier Management Procedure
​Purchase Order Procedure
Medical Device Quality Agreement
Medical Device Quality Agreement - US

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Medical Device Quality Agreement for Europe

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The Medical Device Quality Agreement for Europe includes required agreement content and defined responsibilities between a manufacturer and a distributor of medical devices per the legal requirements specified in Medical Device Regulation, MDR (EU) 2017/745 and ISO 13485:2016.

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Master Consulting Agreement

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The Master Consulting Agreement is a robust and mature agreement designed specifically to support medical device consultants. This product is a must for individuals or companies entering the medical device consulting field.
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Supplier Management Procedure | ISO 13485 | FDA QSR Compliant

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The ISO 13485 Supplier Management Procedure governs the review, approval and continuous monitoring of all suppliers to ensure conformance to regulatory requirements. 
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Purchase Order Procedure | ISO 13485

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The ISO 13485 Purchase Order Procedure establishes the process for purchasing materials, products or services and the methods utilized to maintain purchasing data. The Purchase Order Procedure applies to all purchase orders placed by the Purchasing Department.
  • ISO 13485:2016 Compliant
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  • 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
      • 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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