The responsibility of a medical device manufacturer in Saudi Arabia does not end with the release of the device. According to the ISO 13485 certification required by the Saudi Food and Drug Authority (SFDA), the following are some tips for measuring the performance of a product post release:

  • Make sure to handle complaints effectively.
  • Regularly report events to the regulatory authorities.
  • Have a continuous internal process for product evaluation.
  • Identify and separate non-conforming products.
  • Make sure to diligently analyze data and document significant findings.

For further guidance it is recommended to contact top ISO 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].

 

 

Menu