sitem-insel AG

Stefano Adami

Competence Cluster Lead & Senior Consultant, Confinis ag



Modules

Medical Device Regulatory Affairs and Quality Assurance:


Biography

Stefano Adami, Senior Consultant and Competence Cluster Lead at confinis ag, holds a BSc in mechanical engineering and a master in sustainable management and has 15+ years of experience in medical devices development, manufacturing, quality management, and regulatory affairs. He worked for 10 years at Limacorporate, a global orthopedic company, leading the Regulatory Affairs Department attaining products certifications worldwide and with responsibilities for all post market surveillance activities and, ad interim, managed the department for process validations and supported product development projects. As part of his role he established risk management processes, maintained risk management files for continuous compliance and updating with post market data and clinical experience. His experience in risk management continued at ZimmerBiomet and Sequana Medical where he covered several roles in quality and regulatory departments. Within confinis he consults from start-up to global medical device companies for compliance in quality and regulatory, some of them getting their first product to the market thanks to confinis team.