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Quality at Cortex

Quality is one of Cortex Implant company’s core values. The Cortex team is comprised of highly professional and qualified personnel who all contribute, each with their own expertise, to cooperatively create the high standards we uphold. Integrity and transparency are an integral part of the organizational culture, enabling the ability to offer products upholding the highest of standards
Cortex Implant Industries GMP-certified in-house manufacturing facilities allow it to efficiently produce commercial quantities of implants and clean room meet/exceed all US, EU, cGMP requirements.
We have a premium production facility that is dedicated to providing revolutionary products. Each and every one of our products is produced to the highest level of standards – and we are regulated by a number of governing bodies.
Cortex is authorized to operate within USA and the  EEA  and all regulating bodies have given their approval to Cortex. We have invested a significant amount of resources to ensure that we maintain high quality in our manufacturing processes.

Quality Assurance

Cortex products are all subject to strict quality control at every stage of production. Products are marked with batch numbers, and all raw materials are monitored from the moment of their arrival.

Cortex has gain and work according to the following standards:

  • – CE  marking – Certificate Number 867 CE
  • – EN ISO 9001:2008– Certificate Number 867
  • – EN ISO 13485:2012 – Certificate Number 867B.
  • – FDA approval for marketing under 510(k) :
  • – CFDA – Chinese regulation and marketing certificate

certificates

Declarations of Conformity for medical device products are available upon request.

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