Margarita: Margarita is the Lead Link of the team Regulatory Roles and Virtual Manufacturing at Johner Institut. With over 15 years of experience in regulatory affairs, she supports clients as a qualified MDSAP auditor, external quality management representative in accordance with ISO 13485 (section 5.5.2), and as an external person responsible for regulatory compliance in accordance with Article 15 of the MDR/IVDR. She and her team act as authorized representatives in the EU, Switzerland, and the United Kingdom, as well as serving as a US Agent in the United States. Her extensive expertise ensures compliance with local and international regulations.