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Company presentation

Regulatory and technical consultancy for Medical Devices, Cosmetics and “Borderline”

Management Systems and Compliance Product for over 15 years.
 





Furatena is a consulting company founded by professionals with over 15 years of experience on the field of designing, manufacturing and marketing of medical devices and cosmetics
Based on a strong know-how acquired over time “on the field” and following the developments in the sector, the company supports the Italian and foreign companies also in more general topics of the consultancy on Management Systems and Product’s Conformity Marks.
 

Medical Devices

•  Consultancy on certification of Management Systems with reference to the standard ISO 13485, for companies that design, manufacture and sell Medical Devices and/or offer services or processing related to Medical Devices.
•  Consultancy on EC marking of Medical Device, belonging to any class of risk;
•  Performance of Part II audits for the qualification of contractors / distributors;
•  Consultancy on advertising’s authorization for Medical Devices on the Italian national territory;
•  Performance of risk assessment for Medical Devices;
•  Registration of Medical Devices at the Italian health ministry for European and non-European companies wishing to sell in Italy;
•  Role of EC representative for non-EU companies wishing to commercialize •  Medical Devices in the European market, as required by Directive 93/42/EEC and following amendments;

“Borderline” Medical Devices

•  Consultancy on identification and classification of “borderline” Medical Devices;
•  Cosmetics;
•  Consultancy for certification of Management Systems with reference to the standard ISO 22716, for companies that manufacture and sell cosmetics;
•  Performance of Part II audits for the qualification of contractors / distributors;
•  Product’s labels conformity evaluation;
•  Cosmetic’s registration into European Database (CPNP);

Quality and safety

•  Consultancy for certification of Management Systems with reference to the standard ISO 9001;
•  Consultancy for certification of Management Systems with reference to the standard OHSAS 18001;
•  Consultancy on EC marking of Individual Protection Devices;

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    September 15, 2010

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