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ISO-13485-1024x318-white
ISO-9001-1024x313 white

Quality & QMS

  • ISO-13485-1024x318-1024x318
  • ISO-9001-1024x313-1024x313

QUALITY POLICY

The quality policy of CATEH Ltd. is to provide products that meet or exceed customer expectations, comply with all applicable regulations, continually improve in everything we do, striving to deliver high quality products with on-time delivery and superior services to achieve total customer satisfaction, and maintain the effectiveness of the quality management system.


This is accomplished by establishing a culture of teamwork, personal responsibility for work, creativity and integrity.
Our quality management system using the ISO 13485:2016 and ISO 9001:2015 standards as our benchmarks.

 

CATEH-cert_13485_web
CATEH-cert_9001_web

Why Choose Us

CLEAN ROOM

CATEH produces its custom-made medical devices for a particular user with additive technologies in a “Clean Room” designed according to the requirements for clean production and validated according to ISO 14644-1:2015 and the EU GMP standard of the purity class.

QMS & MDR

Influenced by the globalization of the market, and in order to maintain and improve the market position and increase competitiveness, CATEH Ltd. strives for excellence of products and services guided by the demands and expectations of customers. An essential basis for success in this direction are implemented quality management systems ISO 9001:2015 and ISO 13485:2016, all of which we have harmonised according to the relevant provisions and directives prescribed for medical devices made to order according to MDR (EU) 2017/745.

9+ Years of Experience

The first implant was made in 2014. We used to work with the three largest university hospitals in the country. More than 25 patients to whom we solved the problem. Seven leading neurosurgeons in the country have simplified and accelerated operations.