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....... (a) 'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease,....... .and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; ...................
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.

DMG ITALIA is characterized by its research activities and distinguishes itself by being able to gain patents and by the capability to create technical files, which comply to European Notified Bodies' requirements for medical devices.

After having obtained in 2002 the Approval of Quality Assurance System for production and/or sterilization, according to Annex V of EC Directive 93/42/EEC, by the Istituto Superiore di Sanità, Notified Body N° 0373, we have furnished our company with the ISO certifications for research and development, production and trade of Medical Devices.