CONSOBIOMED
Consortium
MIRANDOLA’S "BIOMEDICAL DISTRICT"
Mirandola is an industrial and
agricultural town, 30 km. North-East from Modena, the worldwide famous town not
only for the tenor Pavarotti, but also for its mechanical and race cars
industries and, in particular for two of them: Ferrari and Maserati.
But Modena can offer even more.
Since 1964 in the territory of Mirandola, a thriving biomedical industry has
progressively developed. It was at first specialised in disposable products for
heomodialysis, plasmaphereris, transfusion and infusion therapies and,
afterwards, in the design and production of the machines used for the above
technologies.
The people of Modena, with
their characteristic humor, have called this region "plastic valley",
making a comparison, probably a little bit hazardous, with the Californian
"silicon valley". In fact, only in the United States we can find a
concentration of producers like Mirandola.
All greater world groups are
here, and the series complete of biomedical components are made. Different
multinational and national groups (Sorin-Snia, Gambro, Mallinckrodt, Fresenius,
Baxter, B.Braun and others) attracted by the technological background that the
territory offered, have installed or bought companies in this area, contributing
to develop this industrial field.
In the last decades, the largest industrial
groups grew but there has also been a strong
diffusion of this specific "production culture" which has brought to
the birth and the development of many small companies for production and
services in the biomedical field.
These companies have a strong
dynamism and if for many of them the beginning was working for important
industrial groups, their point of arrival has been the complete commercial
freedom on the markets both for the finished products and services.
CONSOBIOMED is a consortium
founded in 1990 with the charter to help small and medium companies of the
biomedical field to face quality problems related to the European Norms and to
the CE mark. CONSOBIOMED has also the commitment to support and co-ordinate
activities in order to increase commercial exchanges of the associated
companies.
In 1999 CONSOBIOMED has become
a consortium for export with a strong commitment to quality and safety
requirements.
Today the consortium includes
small and medium-size companies, technologically high-skilled and with dynamic
and flexible production capabilities, which main objectives is the development,
production and export of medical devices in conformity with the Laws and Norms
of the sector.
Thanks to its resources, the
association with Assobiomedica, and to the agreement with companies and
specialised bodies, the consortium is able to support the associated companies
in their commercial and promotional activities towards foreign markets, through
the following services :
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National and International
Trade Shows by organising fairs, travels, visits of consortium associates
abroad and of foreign operators to Italy;
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Research and promotion by
mailing, advertising, organising of conferences, etc;
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Consultancy on quality
systems, 93/42/EEC Directive and specific regulations of EEC extra
countries;
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Training courses on export
and norms about production in accordance with national and international
dispositions of the sector;
-
Controls of clean-rooms.
SERVICES ON EXPORT OFFERED BY CONSOBIOMED
National and International Trade Shows
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List of national and
international trade shows and commercial demonstrations.
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Group attendance to
specialised trade shows abroad.
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Organisation of trade
shows, travels and visits of CONSOBIOMED associates abroad.
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Request of sunk capital to
CCIAA or to the Emilia Romagna Region.
Promotion and Research
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Organisation of visits for
foreign guests to Italy.
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Organisation of meetings
with potential customers.
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Advertising on specialised
magazines.
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Promotion of the associated
companies on the CONSOBIOMED Catalogue.
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Acquisition of information
on foreign and/or national markets
Management of Relationships with Official
Entities
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CAN – National
Association of small industry (to obtain customised financing)..
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Italian and foreign
Chambers of Commerce.
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CERCOMES – Foreign
Institute of Chambers of Commerce Emilia Romagna.
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Consulars and Embassies.
- Exchange of information through the
"Gazzettino of CONSOBIOMED", weekly
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magazine dedicated to the
associated companies.
Consultancy
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Assistance on the clear off
procedures for the commercialisation of medical devices in extra-European
countries.
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Assistance in the
interpretation and application of Directive 93/42/EEC and its Italian
adoption.
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Assistance in the
interpretation and application of Quality Systems ISO 9001 / EN 46000 and
their evolution (Vision 2000). More in general, CONSOBIOMED assists with the
norms that regulate the production and commer-cialisation of medical
devices.
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Finding and updating of
sector norms and laws.
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Assistnace in the
importation of raw materials and half-finished products to be used by its
associates.
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Fulfilment of obligations
due to the authorities within the surveillance system.
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Intermediation contacts
with Assobiomedica (National Association for the biomedical and diagnostic
technologies).
Courses
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Training courses on quality
systems and product certification (Cemark).
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Training conferences on
specific topics.
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Courses on management
control, commercialisation and export on small-medium companies of
biomedical field with the observation of the sector laws.
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Specific training of
personnel within the company.
Controls for Clean-Rooms
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Assistance in the
validation, re-validation and routine controls relevant to clean-room,
laminar flow hood and sterilisation processes.
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Particles contamination.
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Microbial contamination of
air and surfaces.
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Particles and microbial
contamination of laminar flow hood.
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Physical parameters.
MORE DETAILS ON THE CONSORTIUM
CONSOBIOMED is a consortium of
biomedical companies which share the different problems related to the sector
and several objectives in the export field.
The requirement to product in
observance to the international quality standards and in accordance with precise
dispositions of the law, has initially incited different small companies to
create the consortium. The commercialisation abroad of the products offered by
the associates has consequently started.
In that way, CONSOBIOMED
supports its associates sharing information, competencies, people … and time!
Companies of any establishment
and both public and private associations can join CONSOBIOMED, which is a
consortium with limited responsibilities.
The Consortium is no-profit and
its only purposes are :
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