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MEDIQUASAR CONSULENZA

Italy

With the experiences I acquired the following skills: to make/prepare the Clinical Evaluation Based On The Literature, to extension of an existing clinical evaluation ; to resolve the issues concerning the regulatory aspects of: classification of the specific type of the product, CE, marketing authorizations, import / export permits, verify the accuracy of labeling, compliance with the requirements of 'U.S. FDA 510 (k) Medical Device Submissions Requirements, preparation of the technical documentation for medical devices, etc.; to know the requirements on Clinical Investigations; to know the ISO 14155: 2012; to translate.

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