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Tecno-med Ingenieros

Ed Forum Tecnologia, A-128 C/Marie Curie s/n
Barcelona, E-08042 Spain
Tel: +34 93 2917739
Fax: +34 93 2917740

E-mail: xcanals@tecno-med.es

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Description:
Provides services for the CE marking of IVD medical devices, including preparing technical files and quality systems. The company offers consulting for quality systems according to ISO 13485:2003, ISO 9001:2000, and ISO 15189; prepares risk management reports according to ISO 14971; and can prepare and submit 510(k)s to FDA.

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