WHAT IS THE MEDICAL DEVICE STANDARD?
ISO 13485: 2016 is an international standard that defines quality management system requirements for medical device manufacturers.
When medical device manufacturers are active in the world market, the focus on international standards such as ISO 13485, not only gives great advantages, but it can also be a contractual obligation established by current legislation or customers, therefore, various countries have incorporated ISO 13485 into their regulatory systems, because compliance with this standard can be used to support compliance with current regulations.
ADVANTAGES OF AN ISO 13485 CERTIFICATION
Reach customer expectations by meeting regulatory requirements.
Demonstrate the level of quality.
Document processes transparently.
Facilitate harmonization between regulatory requirements for medical devices and quality management systems.
Reduce the risk of liability documented according to security management.
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