Among the many requirements of the ISO 13485 certification as required by the Saudi Food and Drug Authority, product design is one of the important ones. As per the ISO 13485 certification standard, product design involves proper verification as well as validation of the medical device in question. Consultants are of the view that if manufacturers in Saudi Arabia endeavor to establish the required design controls, they should focus on the following issues:

• Where the device will be supplied and used.
• Requirements for the proper operation of the device.
• Making sure that the device provides the correct service and expected outcomes.

For ISO 13485 Certification, ISO 13485 Consultancy, ISO 13485 Consultants, ISO 13485 SFDA requirements, in Riyadh, Jeddah, Dammam, Jubail, Yanbu, Hofuf drop an email to [email protected].