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Founded in 2002, ENKI is a company specialized in the design, prototyping, engineering, and OEM production of medical devices across all risk classes.

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Evolution and continuous improvement

ENKI's expertise in cleanroom microtube extrusion has fueled consistent growth over the years, expanding capabilities in extrusion, component design, braided tube production, and high-performance medical balloons manufacturing.

In addition, ENKI offers OEM production of finished and semi-finished complex devices within cleanroom environments. ENKI holds certifications for ISO 9001:2015 and ISO 13485:2021 standards. ENKI's production facilities adhere to ISO Class 10,000 cleanroom standards, including ISO 6, ISO 7, and ISO 8. Furthermore, R&D prototyping activities take place in ISO 7 environments.

In 2017, ENKI underwent a management change and corporate restructuring, leading to significant investments and a strong focus on quality. This philosophy drives continuous improvement of technologies at all levels, as well as production and organizational processes.

Central to this restructuring was the formation of a highly qualified and dynamic team, with a shared philosophy of flexibility and efficiency. Our goal is to be a reliable partner, capable of promptly and effectively meeting the needs of our clients. We encourage collaboration among diverse roles and perspectives to stimulate creativity and develop solutions aligned with our rigorous quality system, essential for a company focused on the medical sector.

The core concept of ENKI is to provide a complete solution for those looking to develop new medical devices or components. Our established experience and integrated technologies facilitate the smooth transition from embryonic ideas to prototype development and subsequent production.

ENKI's client portfolio includes major European companies specializing in catheter production, including for the US-FDA market.

By relying on ENKI, one can efficiently transition from the ideation phase to design, feasibility study, material selection, and prototype creation. Our lean yet rigorous approach reduces transition times between project phases and eliminates compatibility issues, ensuring a cohesive and efficient process.

The current phase of organizational, technological, and qualitative development focuses on process optimization, improving communication effectiveness, ensuring a traceable and secure data flow, and embracing digitization to enhance production capabilities.

Numerous projects are currently in development, spanning from the early stages of engineering to pre-series for clinical studies. ENKI thrives in a dynamic environment, constantly oriented towards improvement and delivering high-quality products to our customers.

Certifications

For greater assurance of quality and reliability in our work, ENKI is certified

UNI EN ISO 9001:2015
ISO 13485:2016

EN ISO 13485:2016 / A11:2021
UNI CEI EN ISO 13485:2021

ENKI's cleanrooms, ranging from ISO Class 10,000 to ISO 6, ISO 7, and ISO 8, are continuously monitored to ensure suitability for medical processing.

Turning your ideas into reality

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