BS7017 Regulatory Control of Healthcare Products and Medical Devices

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, 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.

1. Provide advice on the medical device approval processes in the US and EU.
2. Develop the technical requirements for a risk-based medical device approval process.
3. Create a medical device design process that meets global regulatory requirements.
4. Apply risk management concepts in the design and development of medical devices.
5. Apply quality management principles in the design and production of medical devices.
6. Critique on the adequacy and efficacy of the different medical device frameworks.