COURSE CURRICULUM

The MSc in Process Validation and Regulatory Affairs (Medical Technology) is designed to develop advanced expertise in quality management, regulatory compliance, and process validation within highly regulated manufacturing and medical technology environments. In Semester 1, students study Advanced Process Management, which focuses on manufacturing systems, process design, automation, capacity planning, and operational efficiency. Quality Management develops the ability to implement, evaluate, and audit quality management systems while preparing students for leadership roles in quality-focused industries. Regulatory Affairs (Medical) provides a detailed understanding of EU medical device regulations, classification systems, submission pathways, and compliance requirements, equipping learners with professional competence in regulatory practice. A year-long Dissertation begins in this semester, allowing students to conduct in-depth, independent research aligned with industry or academic contexts. In Semester 2, Advanced Regulatory Affairs expands knowledge of global regulatory frameworks, including international standards, guidance documents, and technical writing for submissions. Auditing and Risk Management focuses on risk-based approaches within quality systems and prepares learners to manage external audits and evaluate compliance effectiveness. Process Validation develops practical expertise in validating manufacturing processes to ensure efficiency, compliance, and product quality. The Dissertation continues throughout the program, culminating in a substantial research project. Overall, the program prepares graduates for senior roles in regulatory affairs, validation, auditing, and quality management within the medical technology sector.