Post-Graduate Diploma in Medical Technology - Course Outline
This course is delivered 2 evenings per week online and 1 Saturday per month in person.
A three-semester taught a course in Medical Device Technology & Business (65 ETCS Credits) leading cumulatively to a Postgraduate Diploma in Science in Medical Device Technology & Business.
Module 1: Medical Device Technology
Medical device types and classification, connected health and mobile devices, human anatomy & Physiology, medical device design cycle, value engineering of medical devices, manufacturing, assembly, packaging & testing, and combination products.
Module 2: Medical Device Quality Systems & Regulation
Medical device regulations - ISO 13485, FDA requirements - Class I, II and III devices, statutory frameworks, medical device design, manufacturing, quality management system elements, validation and change control, facility plant design, and product process validation.
Module 3: Medical Measurement and Analysis
Medical data measurements and analysis, distributed databases, data collection systems & data architectures, data analysis software, data storage and data integrity, data management in product and process design of medical devices.
Module 4: Emerging trends in Medical Device
Challenges facing the MedTech sector, the move towards value-based healthcare, growing regulatory pressures, resource constraints, product & process differentiating capabilities, growth initiatives, transforming cost structures and reorganising for sustainability, connected and combined smart medical devices, and software-based medical devices.
Module 5: Strategy, Leadership & the Culture of Innovation
Current challenges of MedTech industry, strategic thinking in the industry, leading change, the culture of innovation, corporate governance and business ethics.
Module 6: Operational Excellence & the Science of Innovation
Origins of operational excellence, operational excellence implementation models, lean sigma implementation, design for six sigma, science of innovation, TRIZ concepts, key performance indicators (KPI), quality function deployment.