The objective of this module is to ensure student understanding of quality standards, quality management systems and frameworks in order to be able to establish, implement and maintain an integrated approach to quality.

1. Critically evaluate quality management system models such asISO 9001, ISO 13485, EudraLex – Volume 4, 21CFR Part 820, 21CFR Part 211.

2. Develop strategies for quality system management implementation and maintenance
3. Evaluate Quality Management Systems against specified requirements

4. Determine the pathway to certification for ongoing registration and compliance with standards
5. Prepare a site for third party audit from certification bodies, regulatory bodies, and customers

This module will provide students with the knowledge and skills required to write technical documents. A number of industrial case studies will be presented by guest lecturers to facilitate the analysis of topical issues in quality.

1. Identify the target audience and apply the concepts of writing technical documentation to suit the competence of the target audience.

2. Present documents in a clear, concise, consistent and unambiguous style.

3. Reference sources in technical documentation using Harvard style referencing system.

4. Critically analyse graphics and text.

5. Apply knowledge of quality management to interpret and report on case studies based on quality issues that may arise within an industrial setting and identify how these issues may be resolved.

This module will give students an understanding of the four phases of design and development from product concept to manufacturing with particular focus on understanding and ensuring market needs, user requirements and regulatory compliance.

1. Explain the four phases of Design and Development that meet standards/regulations including relevant ISO and FDA standards and regulations.
2. Evaluate product design to ensure compliance with requirements such as essential safety and performance requirements of US and European directives and regulations
3. Plan new product introduction including process design and product transfer operations
4. Conduct product design reviews, verification and validation
5. To have an understanding of key design input requirements including software, electrical safety, radiation, mechanical, usability and user interface criteria.

This module will provide a deep understanding of the regulatory pathways for medical devices and pharmaceuticals in Europe and the US and also provide an introduction into the requirements of what is required to gain access to other global markets.

1. Examine the regulatory pathway for medical devices and pharmaceuticals when seeking market approval in the EU and the US and other jurisdictions

2. Evaluate how and why the regulatory environment for medical devices has changed in Europe over the last few years.
3. Explain the various types of technical documentation required when seeking market /regulatory approval.

4. Determine the requirements for conductingclinical evaluation/investigations for Medical Devices.

5. Compare and contrast post marketing surveillance requirements in US and Europe.

This module will provide the student with the statistical tools necessary to analyse industry related problems where data is generated. The student will also be introduced to Experimental Design which is a technique used to study causal relationships by maximising the amount of useful information obtained with the minimum number of experiments. The application of these tools will allow the student to perform Problem-Solving activities and optimise products and processes using Six Sigma and/or other continuous improvement strategies.

1. Create an appropriate hypothesis test for a given problem

2. Conduct appropriatestatistical tests on data

3. Evaluate the results and implications of statistical tests

4. Specify an appropriate experimental design for a given application e.g. screening, optimisation, comparison etc.

5. Createand interpret an experimental design (DOE)