Dr. Mario Gennari is an experienced regulatory and quality based professional, working in the Medical Device, In-Vitro Diagnostic and Pharmaceutical Industries for over twenty years. His core expertise is in the Regulatory Requirements and Quality Management System, including Design Control, Process validation, Tests Methods Validation, Management experience in sterilization technologies and their validations clinical investigations/evaluation, PMCF in compliance with MDCG, ICH GCP and FDA guidelines and audits at sites of investigational products, clinical analysis labs. In addition, he has specific expertise in R&D and quality requirements for Medical Devices, Diagnostics and Combination products. This has included the writing, implementation and maintenance of Quality systems, auditing of external suppliers and manufacturing/distribution sites and due diligence auditing. He also has extensive experience in the application of Design Control and post market surveillance systems for Complaints Management and Vigilance Reporting, Process Validation, CAPA, risk management and Clinical studies.

Location: Modena – Italy