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.