Regulatory Affairs (TK)


This module will deal with the Quality Assurance systems and quality management principles needed in manufacturing and specifically in the building of automated machines and automated systems.

The course will cover both European Union (EU) and US regulations and related agencies. 

Learning Outcomes

  1. Discuss the role of quality management in Manufacturing and the constraint linked to its implementation.

  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. Investigate and discuss the role of automation in quality control.

  4. Discuss the regulatory requirements that affect the development of automated systems and their impact on the design.

  5. Discuss the sustainability aspects that are relevant to medical devices.

% Coursework 50%
% Final Exam 50%