ISO 13485

The ISO 13485 certification is the Quality management system set up for the manufacturers and suppliers of medical devices.

Although the certification standards mirror the same prerequisites of ISO 9001, there are additional prerequisites such as customer feedback, process control, design control, saving of records, transparency, traceability, etc.

The ministry of health in the UAE, Egypt and other Middle East regions, has made ISO 13485 certification mandatory for organizations manufacturing and trading medical devices.

We at URS-Middle East have in-depth experience and knowledge to verify, and assess the quality management system of your organization, and help you achieve this certification. The certification will endorse that your organization’s quality management system meets the industry and regulatory requirements.

Benefits of ISO 13485 certification:

  • Guarantees high quality of provided medical devices
  • Reduces production loss rate
  • Reduces operational costs
  • Increases effectiveness across the whole organization
  • Increases your customers‘ trust in you as a safe supplier or producer

Certified organisations can include URS and UKAS logos in their promotional activities.


Download a leaflet in PDF

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Why Choose URS?

  • URS is a holder of the international accreditation UKAS - United Kingdom Accreditation Service.
  • More than 40,000 contracts from 40 countries have attested to the high quality of URS Holdings services.

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