International quality certificates

ISO 13485 ce organizations who develop medical devices & apps

About the Standard :

This certificate has been designed by organizations involved in the design, production, and equipping of medical devices related to external employees, such as certification bodies, to assist them in their audits.

The development in the field of medical devices requires a level of understanding of the regulatory environment and the duties and obligations involved

Benefits of ISO 13485 CE Certificate

Ensure that the requirements of the product are correct and complete

Risk analysis

Focus on the user to develop products

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