At Cortex, quality is an integral part of the way we do business.
Quality is one of our company’s core values. We believe that in order to provide quality products and service to our customers, we need to live and breathe quality at all times.
Our 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 our organizational culture, enabling us 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.

 

International Regulations

As a regulated manufacturing facility, Cortex is fully compliance with all European directive for Medical Devise EN 93/42/EEC and ISO 13485:2012. Our facility is inspected on a regular basis by European Notified Body  to ensure we are comply the requirements set forth by ISO & CFR 820(QMS) Standards.

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.

Cortex had 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

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

 

warranty

cortex has complete confidence in the quality and durabillty of the products we deliver.

therefor we offer a 15-year guarantee to all of our products.

provided they are used properly and in accordence with our instructions.