ISO 13485 – Medical Devices Quality Management

Medical Device – Quality Management Systems

The ISO 13485 certification is the Quality management system set up for the manufacturers and suppliers or external parties that provide product 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, Saudi and other Middle East regions, has made ISO 13485 certification mandatory for organizations manufacturing and trading medical devices.

We at URS 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.

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


Are you interested in this certification?​

If you are interested in this certificate, do not hesitate to contact us through the Enquiry Form.

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