random access device - Radim S.p.A.

TECHNOLOGY
CUSTOMER CARE
QUALITY SYSTEM
RADIM S.p.A.
Radim is an Italian Group of manufacturing companies of fully integrated in-vitro
immuno-diagnostic systems, with Headquarter in Rome. The company’s core
activity is research, development and production of immunodiagnostic products
(reagents and instruments).
The Company is made up of 230 people working in two main facilities:
Radim, located in the industrial area of south Rome, whose core activity is
research, development and production of immunodiagnostic kits to effect diagnostic
tests in Infectivity, Allergy, Hormonology (including Oncology), Plasmaproteins,
Food Intolerance and Autoimmunity.
Seac, located near Florence, focused on research, design and production of automated
instruments for Immunometry, Haematology, Clinical Chemistry, Coagulation,
Nephelometry and Flame Photometry for the domestic and international
market.
Three Subsidiaries sited in Spain (Barcelona), Brazil (Sao Paolo) and Germany
(Freiburg) operate as reference centers for the foreign markets and a global network
of distributors in over 50 Countries ensures worldwide sales and service.
Since its foundation in 1980, Radim has always based its activity on continuous investments in in-house
research and know-how, involving different skills and competencies to get the best results in terms of
performances. A considerable part of financial resources are dedicated to internal Research activities and to
cooperation with domestic and international Academic Institutions. 30% of the Company human resources is
dedicated to the development of new technologies, analyte panels and advanced Random Access automated
systems.
The development of diagnostic kits begins with research on raw materials and cell cultures for the production
of monoclonal antibodies, native and recombinant antigens. Adopting different biochemical procedures, antigens,
antibodies and allergens are purified for use in conjugation, labeling and coating. These activities are crucial
in the strategy of the Company for the development of new diagnostic tests.
A highly qualified staff takes care of the daily laboratory trouble-shooting, by offering “on-line” technical and
scientific support. Immediate information concerning our diagnostic products and the use of our instruments
is provided to our customers. An efficient team of local specialists is able to diagnose and solve any sort of technical
application problem and will intervene directly on site whenever necessary.
A network of highly qualified Service Engineers is immediately available, both nationwide and internationally,
to solve any functional problem with our equipment. We also hold dedicated Technical Assistance training
sessions in all our Group facilities for our local distributors. This ensures an efficient and independent service
worldwide.
The Company is Quality System Certified UNI EN ISO 9001 and UNI EN ISO 13485: 2004. This means giving
priority to high quality standards in each individual sector of the working process, whether it be in terms of
production, distribution or customer satisfaction. Each product and equipment is CE marked, as required by
the IVD European Directive (98/79/CE).
Moreover, each phase of manufacturing cycle is strictly subject to quality control, from raw materials up to final
product testing.
Furthermore Radim has obtained the certificate of ISO 13485 : 2003 (TUV America INC) according to CMDCAS,
Canada.