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Daniele Lioi is a Senior Consultant and Team Manager of the Eurofins Medical device consultancy team. Since 2017, he has been dealing with biological risk assessments, clinical evaluation and supporting the compilation of the technical documentation for medical device manufacturers, including substance-based medical devices. He has a biotechnology background with experience in regulatory affairs of medical devices. Daniele recently obtained the qualification as Auditor/Lead Auditor ISO 13485/ISO 9001, he is included in the national registry for person responsible for regulatory compliance and has joined the HAS consultants team for the harmonisation of International Standards.