Regulatory Control Of Healthcare Products Medical Devices

AY2018/2019 Semester 2

This 13-week programme provides a complete and concise treatment of the key considerations in the development and regulation of healthcare products. The main area of concentration is in medical devices and is divided into four parts. The course begins with a historical introduction into the healthcare products industry and the start of regulatory controls. It then moves into the core principles of healthcare products regulations and expands into the methodologies of ensuring compliance with regulatory requirements. This includes going through the fundamentals of Good Manufacturing Practices, quality management systems, product risk classification, risk management and the different regulatory systems in the world. At the end of this course, you should have a clear understanding of healthcare products regulations and able to apply these requirements in product development. You will also be required to perform casework to test their ability to apply these concepts in real scenarios.