Quality and Regulatory Affairs - BSc

Semester 1

Introduction to Quality Management

The aim of the module is to give an effective and functional overview of Quality Management. It will introduce the role Quality Management plays in the workplace, how to implement a range of quality strategies and tools, and the impact that quality has on the organisation as a whole.

Quality Science

This module aims to provide an understanding of Multiple Regression, two-way analysis of variance; Design of Experiments Fractional and factorial designs, Taguchi methods, EVOP (evolutionary operation) experimentation; Advanced Six Sigma Statistics, Process capability indices - Cp, Cpk etc., R&R studies, machine capability.

Problem Solving Tools & Techniques

The aim of this module is to help students Understand the principles of 6 Sigma and how they can be implemented in the manufacturing and service sectors to deliver strategic objectives.

Semester 2

Medical Device Science

The module aims to provide an overview of medical engineering materials and their functional properties, exposing the student to the practical application of design, materials, mechanics and strength of materials theory as applied to medical devices.  There is a focus on the appropriate use of Standards, Charts, and Design Guides and EU directives on Medical Devices.

Bio Compatibility & Device Design

Biomaterials and their biocompatibility are critical components of medical device design, tissue engineering and cell therapies. This module provides an overview of all major biomaterials. It introduces generally the different classes of biomaterials and focuses on the ways in which these materials interact with biological systems. It introduces biomaterials for different applications, and characterises biomaterials in terms of their structural, physical and biological attributes

Fundamentals in Regulatory Affairs

The aim of the module is to introduce participants to the Fundamentals of Regulatory Affairs, providing them with basic knowledge of the regulations as they apply to the medical technology industry. This module will cover international regulatory requirements with emphasis on the US, European Union, Japan, Australia, Canada and other global territories with market implications.

Semester 3

Validation Principles & Practices

This module introduces participants to the fundamentals of Validation, providing them with a basic knowledge of the regulations, standards and the skills necessary for validation work in the Medical Device sector. This course will cover international validation requirements pertaining to validation and all associated systems.

Project

The Project module will provide the student with experience in planning a work programme to a defined set of research objectives, in data acquisition and analysis, and the interpretation of the results in the light of a relevant literature review. Applying the concepts learnt on the programme modules, this module will drive an overall project theme of enquiry which will have useful learning outcomes for both the student and relevant company if applicable.

Optional : Career Development Programme