This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of the regulatory pathway for placing medical devices on the market in the EU, the essential requirements of devices and submission types & emerging technologies.

1. Demonstrate detailed understanding and knowledge of the new European Medical Device Regulations (MDR) and In vitro diagnostics Regulation (IVDR)

2. Define the regulatory pathway for medical devices and different submission types to get a device to market and to obtain CE approval including ISO13485:2016

3. Understand how to carry out a gap analysis on your regulatory system

4. Demonstrate understanding of notified body and county specific competent authority roles across Europe and the responsibilities of these bodies

5. Critique and evaluate the political, strategic, logistical, manufacturing; landscape effects in Europe on the medical device industry in terms of new legislation; changing standards and guidances;device issues in the media, political changes in Europe.

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of the regulatory pathway for placing medical devices on the market in the US, US Law (FD&C Act) and regulations, the code of federal regulations (CFR), submission types, change control, post market requirements and emerging technologies.

1. Demonstrate they have detailed knowledge and understanding of the submission types involved by demonstrating a strategic knowledge of the structure and technical contents of the many different submission types from simple registrations through to 510(k)s, PMAs, IDEs, De Novos etc. and appropriate supplements such as a 30-day supplement or an annual report through a series of appropriate essays, assignments and literature review.

2. Formulate and communicate judgements with regard to best practices and strategic regulatory decision making process for devices and demonstrate ability to interact effectively with FDA agents through systems such as a 513(g) or pre-submission process.

3. Analyse and evaluate data from US FDA MAUDE (Manufacturer and user facility device experience) database.

4. Communicate a detailed knowledge and understanding of how to manage change control for a product destined for US market.
5. Source and interpret relevant reimbursement requirements.
6. Develop strategies to navigate the US regulations efficiently in the context of an international market.

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of the labelling, sale and supply regulatory requirements for medical devices. The module also covers the application of risk management to medical devices.

1. Demonstrate they have detailed knowledge and understanding of the content and application of ISO 14971: Medical devices – application of risk management to medical devices & risk management planning and the key components of a risk management file.
2. Implement a risk management plan including risk analysis, risk evaluation, implemetation of appropriate risk controls and conduct a risk/benefit analysis.
3. Communicate they have a detailed knowledge and understanding of the EU/US/Global legislation and regulations associated with medical device labelling and global perspectives on UDI, harmonised symbols, structure of IFU, intended use, contraindications, label / IFU review best practice , elabelling.
4. Demonstrate they have a detailed knowledge and understanding of the legislation and regulations associated with medical device advertising and promotion from EU/US and Gobal perspective and also country specific requirements.
5. Communicate a detailed knowledge of context of off label use/on label use and particular requirements for website content.
6. Evaluate the relevance of social media (twitter, blogs..) and future directions for advertising and promotion. Evaluate the place of physician /customer contact and direct to consumer advertising in promotion strategy.
7. Formulate and communicate judgements from a regulatory standpoint in each step of the risk management process and demonstrate ability to interact effectively with regulatory agents.

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of the regulatory pathway for placing medical devices on the market outside of the US and EU, specifically China, Japan, India, East Asia (Taiwan/Korea etc). It explains the legislation applicable and guidelines available to medical device manufacturers. It also addresses emerging technologies.

1. Demonstrate they have detailed knowledge and understanding of the administrative and legislative structure and requirements for medical devices in key global markets to include but not limited to China, Japan, India, East Asia (Taiwan/Korea etc)

2. Identify key differences between these regulatory systems and that of the EU and US and outline methodology to ensure a device can utilize key documentation from EU and US applications in achieving market approval in the above defined jurisdictions.

3. Source and interpret guidances,regulations and legislation currently regulating medical device classification within these global markets and demonstrate ability to classify devices appropriately.

4. Illustrate they have detailed knowledge and understanding of how to define the regulatory pathway for medical devices in these global markets including complex combination or novel devices.

5. Communicate how to achieve market clearance/approval for a medical device destined for a global marketplace and how to address post market surveillance requirements once a product is placed on the market.

6. Demonstrate they have detailed knowledge and understanding of the complexities of regulatory strategy within global markets and understand the submission types involved through a series of appropriate assessments covering each geographical region.

7. Formulate and communicate judgements with regard to regulatory issues for devices such as country specific nuances connected with entry/exit from each country and demonstrate ability to interact effectively with appropriate authorities.

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of the design assurance process, common sterilization techniques for medical devices, associated standards and validation. It aims to provide a basic understanding of common biocompatibility testing methods and interpretation of results.

1. Demonstrate an ability to generate a biocompatibility testing protocol according to standards.

2. Interpret and apply the ISO10993 standards for the evaluation of the biocompatibility of medical devices.

3. Evaluate sterilization methods under various headings to include packaging, products effects, costs etc.

4. Describe current sterilization methods in use detailing rational and system advantages and disadvantages

5. Demonstrate an ability to develop verifiable design inputs and understand the links to riskmanagement activities

6. Interpret and understand test protocols including risk based acceptance criteria, sample sizes and use of appropriate statistical methods

This module is taken by Level 9 students in Medical Technology Regulatory Affairs and it aims to provide students with a detailed knowledge and understanding of post market requirements for medical devices. Specifically this module aims to develop the students ability to create and implement a comprehensive post market surveillance plan to collect, evaluate and respond to data on device safety and performance after market approval.

1. Demonstrate detailed knowledge and understanding of global PMS requirements with particular emphasis on US and EU.

2. Illustrate detailed knowledge and understanding of post market surveillance requirements and development of a post market surveillance plan that is consistent with the risk associated with the device based on its intended use

3. Understand complaint management and assessment, evaluation and responses to post market data that is risk appropriate

4. Formulate and communicate a post marketing surveillance strategy which meets regulatory requirements

5. Illustrate an understanding of all types of potential field actions including FSCA, CA’s, Advisory notices, recalls including recall letters and types of recalls

6. Understand PMS data analysis including MAUDE and EUDAMED and complaint trend analysis

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. This module aims to equip participants with the requisite advanced knowledge, understanding and skills to perform medical device related research using traditional and emerging research designs informed by a critical awareness of developments at the forefront of legislation and practice in the medical device industry.

1. Articulate and elaborate an understanding of current thinking on the nature of medical device industry challenges and the value of related research in that context.
2. Articulate and elaborate an awareness of the ethical dimensions and philosophical consideration relating to the device industry in a range of contexts.
3. Manage a research project combining independent study, support sessions and supervision effectively.
4. Write a coherent research proposal with an acceptable research question or hypothesis.
5. Conduct a critically focused literature review.
6. Analyse data according to accepted models of analysis, showing awareness of alternative models of analysis and theoretical frameworks.
7. Sustain from the evidence obtained, a reasoned argument and draw consistent and coherent conclusions from the research evidence.
8. Express the relevance and significance of the outcomes/ conclusions of the research project.
9. Reflect self-critically on the outcomes/conclusions of the enquiry and on the research process itself.
10. Write a dissertation which meets postgraduate standards of technical expertise investigating the subject area or testing the hypothesis outlined in the research proposal.
11. Develop the skills to present and defend aspects of their research at seminars, conferences and vivas.