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ISO 13485:2016 - Medical Devices (Quality Management System)

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

ISO 13485:2016 Medical Devices (Quality Management System) certification can help you to:
  • Increase access to more markets worldwide with certification
  • Outline how to review and improve processes across your organization
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations

MQA help you to certify your organization to ISO 13485:2016. Request for a quote now.

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