Scientific, Regulatory Affairs & Quality Manager - i-Sep
MDR AND IVDR: WHAT STRATEGIES TO QUICKLY ACCESS THE EU MARKET FOR START-UP AND SMEs
Wednesday 24th of January 16:30 - 17:15
Patricia FOREST-VILLEGAS is the I-Sep Scientific, Regulatory Affairs and Quality Director. Patricia founded and has been managing the company Biom'Up for 10 years. She has developed a specialized experience in the registration of resorbable class III and frontier medical devices (implantable collagen based devices) and IIb equipment device in both Europe and the USA. She has also acquired strong expertise in quality in this field. She is in charge of supervising the scientific development, the European and American regulatory strategy and the implementation of the quality system of I-Sep in view of an ISO 13485 certification.