Margherita Miccheli is a senior expert in the field of medical devices, with over 10 years of experience in Quality Assurance and more than 9 years in Regulatory Affairs. Since 2024, she has been part of the Eurofins Medical Device Consultancy Team, where she is involved in all regulatory and quality assurance aspects related to device certification in accordance with Regulation (EU) 2017/745 (MDR) and the implementation of an effective ISO 13485 quality management system.
With solid industry experience and over 100 certifications under Directive 93/42/EEC and more than 50 certifications under the MDR, Margherita specialises in supporting manufacturers throughout the entire device lifecycle – from design to post-market – by identifying regulatory strategies and customised solutions to meet applicable requirements and achieve rapid and effective certification. She is also qualified as an ISO 9001 Auditor/Lead Auditor.