Quality Is an Integral Part For Cortex 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. Our facility is inspected on a regular basis by European Notified Body to ensure we are in compliance with 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
  • EN ISO 9001
  • EN ISO 13485
  • FDA approval for marketing under 510(k) :
  • CFDA – Chinese regulation and marketing certificate
  • INVIMA –- Colombia National Food and Drug Surveillance Institute
  • COFEPRIS - Mexico Medical Device Registration
Declarations of Conformity for medical device products are available upon request.

Warranty

Cortex has complete confidence in the quality and durability of the products we deliver.
 
Therefore we offer a lifetime guarantee to all of our implants.
 
Provided they are used properly and in accordance with our instructions.