COURSE CURRICULUM

The MSc in Product Design Control is a specialised, industry-focused postgraduate program designed to prepare graduates for leadership roles in regulated product development environments, particularly within the medical device and wider high-tech sectors. The program centres on Product Design Controls, a structured framework that ensures products are developed safely, effectively, and in compliance with international regulations such as EU MDR, FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62366-1. It covers the full product lifecycle from initial concept and user requirements through design planning, risk management, usability engineering, verification and validation, design transfer, and post-market considerations. Students develop strong competencies in quality management systems, project management methodologies, regulatory affairs, and structured product development practices. The curriculum combines theoretical foundations with applied learning, including case studies, industry-aligned projects, and a major dissertation. Core topics include design control processes, quality standards, risk management techniques, and regulatory requirements for global markets. Emphasis is placed on ensuring that products not only meet user needs but also comply with strict safety and performance standards. Graduates are equipped to work across multiple regulated industries such as medical devices, pharmaceuticals, biotechnology, aerospace, automotive, and advanced manufacturing. The program ultimately develops professionals capable of designing, verifying, validating, and delivering compliant, high-quality products in complex industrial environments.