Quality and Regulatory Affairs

This module will deal with the Quality Assurance systems and quality management principles needed in manufacturing and service organisations.

This course will provide students with an in-depth understanding of the regulations and regulatory agencies that are specific to the medical devices industry. The course will cover both European Union (EU) and US regulations and related agencies. Topics will include the laws covering the regulation of medical devices, regulations related to the development, manufacturing and approval of medical devices, regulatory agencies and bodies responsible for implementing the regulations, how the regulations affect the marketing of medical devices.

1. Discuss and compare philosophies and new trends in quality management and their place in today's manufacturing and service environments including Total Quality Manageemnt (TQM)

2. Analyse and apply a range of statistical tools to measure quality. Select appropriate methodologies of quality improvement and apply various tools and techniques for analysis of quality.

3. Describe the functions of the GMP, EU and US authorities, departments, agencies and other bodies responsible for developing and implementing the laws and associated regulations for Quality and medical devices industry.

4. Descibe the EU and US regulatory requirements that affect the development, manufacturing and quality of medical devices.

5. Determine the classification of a medical device.

6. Decide if an adverse event should be reported and if so describe the correct reporting procedure.