I have dedicated myself to regulatory and quality activities in the medical sector for more than 20 years, providing support in the application of requirements, communicating with Regulatory Authorities, Notified Bodies, national and international organizations and service providers and carrying out regulatory intelligence and strategy activities pursuing the safeguard of patients’ health. Thanks to the implementation and inspection of the specific quality systems, also in compliance with international requirements, I have an in-depth knowledge of the processes applied in the manufacturing companies, in particular design and development, production and related controls, supply chain, marketing and post-marketing. In particular, I am a PRRC and a qualified auditor ISO 19011/9001, ISO 13485, MDSAP. I have supported many companies for CE marking MDR (EU) 2017/745, IVDR (EU) 2017/746, 510(k), De Novo, PMA, Canadian MDL, submissions in other major markets of the medical field.