Clinical Trials of Medical Devices - Prerequisites and Success Factors

The Senior Medical Affairs Coach is a link between enterprises and health market when clinical issues represent only temporary tasks. Clinical trials designed for the German Health market have a central role when it comes to certification and surveillance by a Notified Body, obligatory measures to be taken by the manufacturer after market launch, basis for price negotiation and reimbursement as well as important argument for marketing. Lack of expertise has got many reasons, among them lack of trained and experienced staff, uncertainties interpeting regulatory requirements, choice of a suitable study design, of the appropriate partner from the medical field, insufficient knowledge of financing and eligibility criteria for financial support, among others. Support in the initial phase and implementation provede security and are key success factors.

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