For medical device manufacturers in Saudi Arabia, the ISO 13485 certification is one of the required Quality Management System (QMS) standards. The following are some of the general QMS requirements for obtaining the certificate:

• Always maintain the specified standard.
• Identify and minimize risk.
• Always have written documentation of the active protocols and procedures.
• Remember to adhere to all legal requirements.
• Maintain responsibility for outsourced tasks.

These are some of the general requirements that must be fulfilled to get the certificate. For complete guidance on the process, it’s best to contact top ISO 13485 consultants in Saudi Arabia.

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].