EU regulation and quality management of medical device software MasterClass - US edition

Heidi Naderi brings a decade of specialised experience in medical device regulation, focusing on the EU, UK, and Middle Eastern markets. She has been instrumental in guiding Saudi medical device manufacturers, particularly startups, from initial concept through to full market launch. Her hands-on approach encompasses regulatory strategy, mentoring senior management, and drafting essential technical documentation to ensure market readiness and regulatory compliance. Heidis deep knowledge of multi-jurisdictional regulations, including the UKs medical device regulations, the EUs MDR and IVDR, and the Saudi Food and Drug Authoritys (SFDA) requirements, positions her as a key player in Saudi Arabias regulatory landscape. Her expertise has been critical in helping companies navigate the complexities of SFDA regulations and ensuring smooth product launches. As a lecturer, Heidi has delivered targeted training on EU and Saudi medical device regulations, providing practical insights that simplify complex compliance processes. Her blend of regulatory knowledge and real-world experience makes her a valuable advisor for both startups and established companies, ensuring they meet the highest standards of regulatory compliance.