Master of Science in Product Design Control

Technological University of the Shannon: Midlands Midwest

The MSc in Product Design Control (Medical Device) is a specialised, industry-aligned postgraduate programme that prepares professionals to lead and contribute effectively to regulated product development environments. Product Design Controls are a structured framework which transforms innovation and technology into safe, effective, and compliant products. They ensure that regulated industries design the right product and consistently make it correctly every time. The programme strongly focuses on EU MDR, FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62366-1. This programme develops core competencies across the entire product lifecycle from early concept to design transfer and post-market surveillance.Learners will build proficiency in regulatory and quality requirements, risk management, usability engineering, and structured project management. Through intensive coursework, collaborative case studies, and an applied research dissertation, graduates will emerge capable of designing, verifying, validating, and transferring safe and effective products that meet user needs, intended use, and regulatory expectations. The programme is designed for engineers, scientists, regulatory professionals, and quality leaders aiming to transition into or advance within medical device and other regulated industries (including food, pharmaceuticals, aerospace, automotive, and high-tech manufacturing).