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Quality
Standards & Processes
We have to meet the highest standards in everything that we do. From the development to the 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: TÜV SÜD).
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, while allowing us to operate as an Original Equipment Manufacturer (OEM) for medical devices.
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).
Made in Germany.
CorTec is a young medtech company that was founded in Freiburg, Germany, in September 2010. All of our products are made here in Freiburg, Germany.
ISO-Certified.
For CorTec quality comes first. We always aim to exceed our customers quality expectations.
CorTec is ISO 13485 certified.
Infrastructure.
All of our products are developed and manufactured in our ISO 14644-1 class 6 – 8 cleanrooms.
Certificates
You need more information about our quality policy and our certificates?
Contact us: