What is ISO 13485: 2016?

ISO 13485: 2016 is an international standard that defines the requirements of the quality management system for medical device manufacturers.

When the manufacturers of medical devices are active in the world market, the focus on international standards such as ISO 13485, not only gives great advantages, it can also be a contractual obligation established by current legislation or customers, therefore, several countries They have incorporated ISO 13485 into their regulatory systems, because compliance with this standard can be used to support compliance with the regulations in progress.

It is recognized worldwide as the best among the quality practices of organizations within the medical device industry.
It helps to create a systematic framework in which organizations can control, measure and analyze their processes and customer comments.



  • To reach the expectations of the clients fulfilling regulatory requirements.
  • Facilitate the harmonization between the regulatory requirements of medical devices and quality management systems.


  • Demonstrate the level of quality.
  • Document the processes transparently.
  • Reduce the risk of documented responsibility according to security management.

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