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ISO 13485 Chapter 4 Documentation Package

ISO 13485 Chapter 4 Documentation Package

899,00 €

The ISO 13485 Chapter 4 Documentation Package includes essential documents to establish and maintain an effective Quality Management System (QMS) in compliance with ISO 13485:2016 standards. The package comprises: Quality Manual Document Control Procedure Record Control Procedure Medical Device File Template Software used in the QMS Validation Procedure All related Forms and Tools

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The ISO 13485 Chapter 4 Documentation Package includes essential documents to establish and maintain an effective Quality Management System (QMS) in compliance with ISO

13485:2016 standards. The package comprises:

  • Quality Manual
  • Document Control Procedure
  • Record Control Procedure
  • Medical Device File Template
    Software used in the QMS Validation
    Procedure
  • All related Forms and Tools

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