Sharon Chen is located in Taiwan and is an experienced consultant who supports medical device manufacturers with international regulatory compliance, focused primarily on the US and EU. Her areas of specialization include MDR/IVDR transition, and Quality Management Systems according to QSR 820 and EN ISO/ISO 13485:2016. Sharon’s specialties include EU Clinical Evaluation, EU Performance Evaluation, EU Technical Documentation, and FDA premarket notification, where Sharon assists manufacturers in compiling the documentation and preparing application dossiers meeting all critical regulatory requirements. In addition, Sharon is a qualified trainer for Internal Auditing in compliance with Quality Management System standards. Sharon’s expertise covers medical devices and In Vitro Diagnostics.