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Clinical Eavluation, Technical dossiers, PIF, Preclinical Trials

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We can provide:

Clinical Evaluation according to the last revision MEDDEV 2.7/1 revision 4

preparation of technical dossiers to identify any contraindications and to demonstrate compliance with the provisions of law, for example, to obtain the CE mark Directive (Directive 2007/47 EC); preparation of P.I.F. (Product Information File) in accordance with the requirements of Regulation (EC) n.1223/2009; drafting of the dossier on cosmetics and safety assessments of the same; design and drafting of Operational Management Procedures; assistance in preparing for the audit and for the qualification of suppliers; planning services and cooperation.

Clinical preclinical Trials

Biochem may supply you with consultancy and/or tests in order to demonstrate the absence of pharmacological activity of your medical devices

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