COURSE CURRICULUM

The Regulatory Affairs (M.Sc.) program at SRH University equips you with the essential competencies required to succeed in the international medical technology industry by combining regulatory expertise with strategic and practical skills. Beyond understanding regulatory requirements, you will learn how to effectively integrate them into the development and lifecycle management of medical devices, ensuring safety, compliance, and market readiness. The program covers core areas such as quality management systems, international approval and authorization processes, risk management, and clinical trial requirements, providing a solid foundation for regulatory practice. You will also gain hands-on knowledge in post-market surveillance, health economics related to market access, and the use of artificial intelligence to support and optimize regulatory workflows. In addition, the curriculum explores current trends in medical technology, ethical considerations, and strategic regulatory planning to help you navigate complex and evolving regulatory environments. Elective modules allow you to tailor your studies by focusing on advanced verification and validation methods or strategic regulatory management, aligning your expertise with your career goals. Through this comprehensive and practice-oriented approach, the program prepares you to manage regulatory challenges confidently and contribute effectively to innovation and compliance in the global medical technology sector.