Eonex d.o.o. offers development and production services for orthopaedic aids. Our company specialises in orthopaedic implants, surgical instruments, joint reconstruction technologies and dental medicine.
Our highly qualified team of engineers and designers can help you with the development process of medical devices: from the initial draft, via prototyping and the preparation of registration documentation, to the moment of release for serial production.
In other words, we help physicians, entrepreneurs and innovators such as yourself create and launch next-gen medical devices.
Our company offers a number of services, including: design planning and product development in phases, market and patent research, specifying product requirements (functionality, safety, performance, regulatory and normative requirements), concept generation, 3D modelling, the preparation of 2D drawings, the preparation of a test plan, quality control, the preparation of technical documentation, etc.
In order to identify and address design and engineering flaws in the early stage, we use rapid prototyping technology with 3D printers. The main benefit of this method is quick and cost-effective prototype development, enabling us to identify any deficiencies in the design during the product development phase. In this way, new potential solutions are generated. By selecting the optimal solutions, final products that fulfil every requirement can see the light of day. From the model to the prototype, using CAD/CAM software enables us to program both simple and complex geometries with greater efficiency, as well as shorter run-throughs and greater reliability. With the help of a modern CNC production facility, qualified staff and by using optimal machining strategies, the pieces can be fully processed in one pass through the machine.
The company complies with the Quality Management Standard for medical devices according to ISO 13485, ensuring the delivery of high-quality products for its clients.
We have connections with scientific and research centres, institutes and suppliers, and we provide testing services for prototypes and finished medical devices in order to guarantee their performance and safety for both patients and healthcare professionals.
To what end? By testing functional prototypes, we evaluate whether all the inputs and requirements set during the product development process are complied with.
Regulatory affairs ensure that medical devices are compliant with the applicable law of the European Union and national legislation. They cover everything from the beginning of product research and development to post-marketing surveillance, including the market approval process. These activities include contact and the exchange of information between the company and the regulatory body.
Our challenge is to satisfy our customers’ demands. This is why quality and precision are paramount in each work step.
Eonex d.o.o.
Gospodarska ulica 6
HR-42202 Trnovec Bartolovečki
Croatia
Tel: +385 42 68 44 60
E-mail: info@eonex.one
