Medical Device Design Consultation

MARGOMED S.A.

Lublin, Poland

Margomed specializes in the manufacture of disposable medical devices. including: - infusion sets IS, - transfusion sets TS, - infusion pump extenders, - syringes for infusion pumps with a capacity of 50(60) ml, - syringes for catheters with a capacity of 50(60) ml, and 100 ml, - injection syringes in 2 ml, 5 ml, 10 ml and 20 ml, - medicine cups 25 ml, - urine containers. In addition, the manufacturer provides: - services on injection moulding machines and extruders; - tooling services; - ethylene oxide sterilisation services; - laboratory services. Margomed offers design and manufacturing services for a range of products intended for external companies. These companies can subsequently market these products under their own brand. Margomed also facilitates the customization of goods based on a given pattern or design. For the last 30 years Margomed has been manufacturing medical devices in Poland, and currently all stages of the production process are carried out in Lublin, in our newly built, modern production facility with a total area of 13.000m². Margomed has its own R D department, a design office, and a tool shop equipped with modern machines designed for metalworking and injection moulding, used for the production of our own tooling. Margomed has implemented and maintained a Quality Management System according to ISO 13485:2016 standards, and the company also has the right to mark its products with the CE mark. Margomed products comply with the MDR regulation (EU 2017/745), which sets uniform and stringent standards for medical devices across European Union countries. As a result, Margomed products are fully compliant with current regulations and ensure safe use. Production in the clean-room zone of an area of over 5.000 m² includes injection and extrusion processes of individual elements of products and automatic assembly on highly specialized assembly lines. In 2021 we launched a fully automated assembly process - integrated with packaging – for innovative infusion fluid transfer devices, based on our proprietary and patented solutions. In addition, Margomed also has a modern sterilization line and an own microbiological laboratory. Using our knowledge, years of experience in the medical industry and technical facilities available at Margomed, we implement a continuous process of product improvement by introducing innovative solutions to the produced assortment, placing particular emphasis on product safety, user comfort and environmental impact. The medical devices manufactured by Margomed are used in most of the Polish hospitals.