Quality and Regulatory Affairs


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. In addition, an overview of the medical device regulatory process in Australia, Canada and Japan will be provided.

Learning Outcomes

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

  2. Compare and contrast EU and US and other regulations that affect the basic operation of medical device companies.

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

  4. Demonstrate a general understanding of the regulations affecting medical devices in Australia, Canada and Japan and how they compare with EU and US regulations.

  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.

% Coursework 40%
% Final Exam 60%