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Medical Devices

Since 2004, Health Authorities has integrated in its structure the general subdirectorate for medical devices, and therefore, QualitecFarma® expands its activity by supporting the companies of this area. Nowadays, Health Authorities is the only Spanish organism notified by European Commission, with number 0318, for medical devices Directives.

QualitecFarma® has a specific qualification for the development of clinical and regulatory projects, application of marketing authorizations and CE-mark for medical devices before the notified organism. Nowadays, QualitecFarma® takes part in different qualification projects for auditing the quality systems of medical devices manufacturing and marketing companies, as well as establishing the Clinical Development Program to take new products to First in Human trials.