Mario Gennari

GemarMed srl

GemarMed includes former TÜV SÜD PRODUCT SERVICE (TÜV SÜD PS) officials, experienced quality system and GMP auditors, clinical study personnel, regulatory affairs and quality system professionals, engineers, and computer system validation technical and regulatory expertise. Thus, we not only understand medical technology regulatory requirements, but also the most pragmatic way of complying them. This allows our clients to reach not only their regulatory objectives, but their business objectives as well. The GEMARMED team provides medical technology companies with the highest level of expert advice and hands-on assistance in complying with US and European regulatory, quality system, GMP and clinical data requirements.