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 organizationâ€™s quality management system meets the industry and regulatory requirements.
Certified organisations can include URS and UKAS logos in their promotional activities.
If you are interested in this certificate, do not hesitate to contact us through the Enquiry Form.Enquire Now
SAIF Plus Q1-09, 056/C, SAIF Zone, P O Box 7871, Sharjah, UAE
No.118, Darya Blvd., Sa'adat Abad.
Office #501, 5th Floor, Al Falah Bldg., Plot # C-187, Sector E-18/02, Muroor Road, Abu Dhabi, UAE
Office No.2, Retaj Tower, Al Sadd District, P.O. Box 30725, Doha, Qatar
Near Kalimat Bldg., Yassine Khoreibet Dist., Basrah, Iraq
Download the latest training calendar to
learn more about the courses we offer.