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.