Quality

You need more information about our quality policy and our certificates?

Contact us:

sales@cortec-neuro.com

CorTec_Reinraum

Standards & Processes

We have to meet the highest standards in everything we do. From development to individual manufacturing processes up to the further handling of our products – all areas of work strictly comply with our quality management system.

 

CorTec has implemented a comprehensive quality management system (QMS) according to DIN EN ISO 13485 (notified body: TĂśV SĂśD).

 

High process quality is maintained by continuous internal audits, staff training, and process improvements. This provides an important basis for the certification of our products as well as for our OEM business on the medical device market.
We have established several processes to support the consistency of our quality standards, compliance to the latest regulations, as well as continuous improvement of our  processes.

 

Our processes undergo detailed analyses of failures, modes, and effects (PFMEA).

Cleanroom

In line with our strategy we have established all core manufacturing steps in our cleanrooms in-house.

Beginning with the manufacturing of electrode arrays from raw materials using cutting-edge laser micromachining to the production of implantable cables from medical grade wires and silicone tubing up to the interconnection of electrodes and cables we are performing all manufacturing steps in qualified and constantly controlled environments.

 

The final assembly steps of our hermetic ceramic encapsulations are also carried out in the cleanroom: Once the electronics are sealed in and the electrode cables are joined, the ceramic encapsulation is carefully cleaned, dried and overmolded with medical grade silicone rubber, cleaned again, and eventually packaged for sterilisation.

All manufacturing steps are carried out in ISO 14644-1 class 6 – 9 cleanrooms.