CATEH

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CATEH is a Croataian innovative medtech company specialized in the AM production of Patient Specific polymer medical devices. The company was founded in 1992 and has always been oriented towards application. and the introduction of new technologies in a specialised application. We are a company that believes in the advantages of additive technologies and the application of Industry 4.0 in the production of custom-made inndividual products. Medicine is an ideal area for applying our knowledge and skills in combination with additive manufacturing. Each person is unique in its character traits, as well as in physiological and anatomical characteristics. The use of individual medical devices for the patient, whether it is a model for planning medical surgery, surgical guides for the preparation and placement of implants or on individually adapted implants, facilitates medical procedures for doctors because they can plan the operation in advance, reduce the time of surgery using our products and thus reduce stress and effort in the process, increasing efficiency and helping patients improve their treatment with medical devices specially made for them. Only long-term proven and certified materials are used for our products, which, through advanced methods, provides us with new opportunities to use what was not possible before due to the lack of suitable certified materials and additive technologies. Implemented systems in accordance with the requirements of ISO 9001:2015 and ISO 13485:2016 ensure that business processes are improved, and the management and control of business processes consequently and a higher level of product quality, which are compliant according to the relevant provisions and directives prescribed for medical devices made to order according to MDR (EU) 2017/745.

Profile Description

CATEH is a Croataian innovative medtech company specialized in the AM production of Patient Specific polymer medical devices.

Our medical devices are:

  • moulds for individual bone cement implants
  • 3D printed medical models of the patient for planning surgery
  • individual surgical guides for implant placement and positioning
  • individually constructed custom-made implants

CATEH uses its own development and research, in cooperation with the world’s leading manufacturers of additive production devices as well as manufacturers of materials for them, and on the application of new certified materials in medicine, and as a result of its own research has developed two families of medical devices 3DmoldX individual bone cement implants and EVOPEEK individual implants from PEEK.

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.

The excellence we cherish for the application of additive technologies in medicine is also applied by our team to all our other users in the field of technique and everyday life.

Influenced by the globalization of the market, and in order to maintain and improve the market position and increase competitiveness, CATEH d.o.o. 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.

Who we are

Our team, based on more than 40 years of experience in scientific research into polymer technology, product and tool development, recognized very early on the value of additive technologies in the development of new products. Our team has been intensively researching the use of additive technologies in various industries, from design to medicine, for the past 20 years. At the request of neurosurgeons to solve the problem of making large and geometric complex implants for cranioplasty from bone cement, we have developed our methods of making implants and making 3D printing of the made mold based on the patient’s CT scan. Through our research, we were able to find the most accurate craftsmanship technology and material that allows the doctor to easily make individual implants tailor-made for the patient during surgery. Using our knowledge of mold construction, we have created a new method adapted for additive production and using our 3DmoldX method of making bone cement implants in 3D printing made mold, they can be made geometrically very demanding implants and adapted to the needs of the patient, which was not possible with previous methods. EVOPEEK is our second method of directly making individual implants from PEEK by additive manufacturing that has been developed in collaboration with the world’s leading manufacturers of additive manufacturing devices as well as manufacturers of certified materials in medicine for the same.


Vision

The company is a leader in the development and production of individual polymer-based medical devices by additive manufacturing. Using existing and working on the development of new bio-compatible polymeric materials suitable for additive production, we are developing new medical devices with the aim of improving the quality of life of our patients.


Mission

Our mission is to improve the life and more successful treatment of patients, with our knowledge and technology embedded in our individual products, in order to provide medical staff with the best possible preparation and planning of the operation with maximum ease of use of our products, thus reducing the necessary time for the project with the best possible outcome and positive economic impact. The satisfaction of medical personnel and patients brings benefits to owners, employees, the medical profession and society with our products.​

QMS

 

 

Range of Services

  • Medical devices
  • Patient Specific Implants
  • Medical 3D models
  • Medical 3D design
  • Medical AM
  • QMS

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Croatia, Zagreb
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