Meet our expert:
Regulatory Lead – Global Oversight, Global Regulatory Compliance – EMEA
Francesco is a senior leader with extensive experience in Medical Device business and its European regulations. As an engineer with a major in biomedical field, he has great experience in Medical Device Conformity Assessment, new MDR/IVDR Regulation and regulatory changes.
He is also an expert in QMS design and development (ISO 9001, ISO 13485 including CMDCAS, 21 CFR part 820 FDA regulation) including Post-Market Vigilance, outsourced processes assessment and qualification (OEMs, dealers and distributors).