Curriculum & Course Descriptions


BS7017 Regulatory Control of Healthcare Products and Medical Devices

Course Coordinator: Professor YOON Ho Sup   (email:
Availability: Semester 2
The course 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, students should have a clear understanding of healthcare products regulations and able to apply these requirements in product development. They will also be required to perform casework to test their ability to apply these concepts in real scenarios.
  • Principles of safety, quality, effectiveness and risk
  • Global Harmonisation Frameworks
  • Regulatory Framework in the EU
  • Regulatory Framework in the US
  • Good manufacturing practice, including ISO13485
  • Process-based quality management system
  • Healthcare product testing, including ISO10993 biocompatibility
  • Design review of medical devices
  • ISO14971 medical device risk management
  • Failure Mode & Effects Analysis
  • Risk/Benefit Analysis
  • Postmarket perspective of risk management
Upon successfully completing this course, students should be able to:
  • Provide advice on the medical device approval processes in the US and EU.
  • Develop the technical requirements for a risk-based medical device approval process.
  • Create a medical device design process that meets global regulatory requirements.
  • Apply risk management concepts in the design and development of medical devices.
  • Apply quality management principles in the design and production of medical devices.