ISO 13485 Certification in UAE

ISO 13485:2016 Quality Management System for Medical Devices

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices published by International Organization for Standardization in 2003. The standard provides a framework for a comprehensive management system for the design and manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.

It is especially relevant to manufacturers who wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers

Benefits of ISO 13485:2016 Certification

  • Increase efficiency, cut costs and monitor supply chain performance
  • Increase access to more markets worldwide with certification
  • Demonstrate that you produce safer and more effective medical devices
  • Outline how to review and improve processes across your organization
  • Meet regulatory requirements and customer expectations

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