By your side at every stage of the process
R&D & design
Driving innovation through continuous research and development of materials and medical devices. A collaborative and optimized design and prototyping process.
FAR.Medical collaborates with the main suppliers of technopolymers, in order to find the optimal solution to meet the specifications relating to the future finished or semi-finished product. The customer is constantly updated and involved in the process phases, from the definition of the requirements to prototyping.
Production
Merging scientific expertise and technology to create high-performance products that are fully compliant
FAR.Medical’s aim is to provide innovative products that meet customer needs and regulatory requirements. We produce extruded microtubes, semi-finished products and finished medical devices in a controlled environment and according to the latest technologies, to offer high-performance products.
Technical consulting
Guidance and support in the selection of plastic materials for extrusion and the design/creation of the most suitable tools
The FAR.Medical team has decades of experience in choosing the most suitable materials and equipment for the microextrusion process. We offer dedicated technical advice for process optimization and production cost reduction.
Regulatory consulting
Assistance and support for CE marking, registration of medical devices on the database of the Ministry of Health and technical documentation management.
FAR.Medical supports and assists the client in drafting, reviewing and managing the technical file for obtaining the CE marking of medical devices according to the new European Regulation (EU) 2017/745 and subsequent amendments, analyzing and evaluating every single technical, analytical, qualitative and regulatory aspect. Furthermore, it deals with registrations in Eudamed and in the database of the Ministry of Health.
Quality systems
Consultancy for the implementation of Quality system for medical devices in compliance with the requirements set by target country regulations.
Far.Medical supports and assists the customer in all phases of construction, implementation, review and management of the company quality systems according to the reference regulations. The focus on quality promotes corporate development, increases competitiveness and is the best way for continuous and sustainable growth. Quality is the bridge between Know-how and Know-why.
Continuous search for the solution
Support and full listening
Transparency at every stage
Highest team expertise
We are a reliable and certified partner
Design, prototyping, production
and extrusion in clean room
Medical devices for biomedical and pharmaceutical companies
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Research and Development
Success stories
Many biomedical and pharmaceutical companies believe in us, discover some of the projects we are very proud of.
Consulting in the field of european regulations
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The introduction of the EU Regulation on Medical Devices (MDR) 2017/745 and on In Vitro Diagnosti...
The introduction of the EU Regulation on Medical Devices (MDR) 2017/745 and on In Vitro Diagnostic Medical Devices (IVDR) 2017/746 has determined the need for medical device manufacturers to adapt their technical documentation to the proposed standards in order to market their products.
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Solution
In a field that is constantly evolving, FAR.Medical Solutions has supported dozens of medical dev...
In a field that is constantly evolving, FAR.Medical Solutions has supported dozens of medical device manufacturing companies in obtaining the CE marking of their products in compliance with the EU Medical Devices Regulation (MDR) 2017/745 and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746, as well as in the implementation of Quality Management Systems and ISO 13485 certification.
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Extruders for medical products
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The growing market demand for the production of medical tubes with high-performance materials and...
The growing market demand for the production of medical tubes with high-performance materials and specific designs has led to the collaboration between FAR.Medical and TECNO SYSTEM, a company specialized in the construction of molds and extrusion lines.
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Solution
FAR.medical Solutions has collaborated with the historic Italian manufacturer of extrusion lines ...
FAR.medical Solutions has collaborated with the historic Italian manufacturer of extrusion lines for the development of new medical tubing using different types of technopolymers. The technologies used allow the creation of single or multi-lumen, single or multi-layer and conical microtube.
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The evolution of the Spritztube
Request
MED EUROPE has developed in collaboration with anesthetists the Spritztube Evolution product, use...
MED EUROPE has developed in collaboration with anesthetists the Spritztube Evolution product, used for supraglottic ventilation or tracheal intubation. The company asked FAR.Medical Solution for support in designing a removable armor portion to determine the reduction of damage to the tracheal tissues during the use of the device.
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Solution
FAR.Medical Solutions collaborated with MED EUROPE in choosing the most appropriate materials to ...
FAR.Medical Solutions collaborated with MED EUROPE in choosing the most appropriate materials to guarantee the required performance and the development of assembly processes to have high quality, efficiency and safety.
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Do you need to design and validate a biomedical product?
Contact us and let's talk