Despite repeated insistence from the Saudi Food and Drug authority for getting the ISO 13485 Certification, medical product manufacturers may feel reluctant to get the certificate. This is because the certificate, apparently, doesn’t hold any profitability. However, consultants may disagree with the manufacturers and point out the following reasons for getting the certification:

  • Provides for robust and all rounded product requirements.
  • Establishes a concrete process for risk assessment.
  • Makes the development process user-centric.
  • External quality reviews ensure the efficacy of the development process.

And these are only some of the reasons to get certified.

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].

 

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