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ISO 13485 Certification in UAE

ISO 13485:2016 Quality Management System for Medical Devices

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.

Medical devices when manufactured undergoes certain quality checks which ensure that the devices are meeting standards published by International Organization for Standardization in 2003. ISO 13485 Certification does the same thing which means that a standard framework is built that offers a comprehensive management system for designing and manufacturing medical devices. The main motto of ISO 13485 Certification in UAE is that it facilitates harmonized medical device regulatory requirements so that everything is done properly.

For organizations operating at different levels and tiers in the pharmaceutical and medical devices supply chain, this certification offers requirements and protocols for manufacturing medical devices. This certification is relevant to those manufacturers who wish to demonstrate applicable regulatory requirements and organizations supporting medical device manufacturers as well.

With ISO 13485 Certification in Dubai, a lot of benefits are associated such as:

  • Increased efficiency, cost-cutting and monitoring supply chain performance
  • Increased access to markets worldwide with certification
  • Demonstration of producing safe and more effective products and medical devices
  • Outlining processes to review and improve processes at organizational levels
  • Meeting regulatory requirements and customer requirements and expectations.

With all the above benefits, it is quite clear how important is this certification for medical devices. It helps them meet international standards while assuring quality for being chosen for critical purposes.

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