Medical Technology Regulatory Affairs (MSc)

Applications and Selections

Who Teaches this Course

Requirements and Assessment

Glossary of Terms

Year 1 (30 Credits)

RequiredMTR5101: EU Medical Device Regulatory Affairs - Introduction

MTR5101: EU Medical Device Regulatory Affairs - Introduction

Semester 1 | Credits: 5

This module aims to provide students with a detailed knowledge and understanding of the regulatory pathway for placing medical devices on the market in the EU. It explains the legislation applicable and guidelines available to medical device manufacturers.
(Language of instruction: English)

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of the main EU regulations, directives and their context within the EU legislative framework
2. Source and interpret medical device directives currently regulating medical device classification within the EU and demonstrate ability to classify devices, including complex combination or novel devices appropriately.
3. Demonstrate they have detailed knowledge and understanding of the role and expectations of the manufacturer, authorized representative, notified body and Competent Authority.
4. Demonstrate they have detailed knowledge and understanding of current conformity assessment procedures.
5. Source and interpret ISO13485 and various other relevant standards and guidance documents e.g.. MEDDEVS, NB MEDS, GHTF guidance.
6. Demonstrate they have detailed knowledge and understanding of the essential requirements of each device and how a manufacturer will address and meet each essential requirement.
7. Demonstrate that they have detailed knowledge and understanding of the submission types involved in the EU regulatory system.

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  Deirdre Barrow 🖂
  
•  AIDAN TONER 🖂
  

Reading List

1. "Medical Device Design and Regulation" by Carl T. DeMarco
   ISBN: 289344119-07-01T09:34:08.
   Publisher: Quality Press

RequiredMTR5102: US Medical Device Regulatory Affairs - Introduction

MTR5102: US Medical Device Regulatory Affairs - Introduction

Semester 1 | Credits: 5

This module aims to provide students with a detailed knowledge and understanding of the regulatory pathway for placing medical devices on the market in the US. It explains the legislation applicable and guidelines available to medical device manufacturers.
(Language of instruction: English)

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of the US FDA administrative and legislative structure (FD&C Act) and requirements
2. Source and interpret regulations and guidance documents currently applicable to medical device classification within the US and demonstrate ability to classify devices appropriately.
3. Critique FDA guidance documents, consensus standards, FDA forms etc.
4. Illustrate an understanding of the steps required to achieve market clearance/approval for a US destined medical device including all aspects and types of 510(k), PMA, IDE and De Novo applications.
5. Analyze requirements for device registration, device listing and establishment registration and post market surveillance requirements once a product is placed on the market.

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  Deirdre Barrow 🖂
  
•  SERENA LAWLESS 🖂
  
•  AIDAN TONER 🖂
  

Reading List

1. "Medical Device Design and Regulation" by Carl T. DeMarco
   ISBN: 289344119-07-01T09:34:08.
2. "FDA Regulatory Affairs" by edited by David Mantud, Douglas J. Pisano
   ISBN: 9781841849195.
   Publisher: London; Taylor & Francis Ltd

RequiredMTR5103: Technical Report Writing

MTR5103: Technical Report Writing

Semester 1 | Credits: 5

Technical Report Writing teaches the participant not only the critical techniques a scientist needs to know when conducting research but also how to write about his or her work. Not only is this relevant for a dissertation and assignments but also for generating formal reports such as clinical evaluation reports. Professionals in industry require the skills to share their work with others, to communicate their learning, their discoveries and their failures, thus improving research and thus benefiting the industry as a whole and more importantly, the patient.
(Language of instruction: English)

Learning Outcomes

1. Appreciate the nature and importance of technical report writing and review in industry
2. Evaluate the suitability of research methodologies for the purpose of undertaking research
3. Conduct and synthesise an academic literature search relevant to a proposed dissertation or topic
4. Present the research findings in a critically reflective manner which acknowledges the limitations of the research methods and knowledge prod
5. Critically review the ethical issues involved in the undertaking of clinical research
6. Formulate and compare methods for data analysis and the presentation of results and compare different methods when presenting different results
7. Present a comprehensive dissertation proposal

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  SANDRA GANLY 🖂
  
•  DEMELZA LYNN 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  SERENA LAWLESS 🖂
  

Reading List

1. "Technical Report Writing Today" by Daniel G. Riordan
   ISBN: 33586117-06-30T09:34:08.
   Publisher: Houghton Mifflin Company
2. "Chambers good writing guide" by by Ian Brookes and Duncan Marshall
   ISBN: 0550100873.
   Publisher: Chambers

RequiredMTR5104: Global Medical Technology Regulatory Affairs Part 1

MTR5104: Global Medical Technology Regulatory Affairs Part 1

Semester 2 | Credits: 5

This module 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 Russia/CiS; Brazil/Latin America; Canada/Australia. It explains the legislation applicable and guidelines available to medical device manufacturers. It also addresses emerging technologies.
(Language of instruction: English)

Learning Outcomes

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 Russia/CIS; Brazil/Latin America; Canada/Australia.
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. Critique guidances,directives and legislation currently regulating medical device classification within these global markets and demonstrate ability to classify devices appropriately.
4. Articulate an understanding of how to define the regulatory pathway for medical devices in these global markets including complex combination or novel devices.
5. Demonstrate they have detailed knowledge and understanding of how to manage change control from a global point of view.
6. Source and interpret reimbursement requirements.

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  Deirdre Barrow 🖂
  
•  AIDAN TONER 🖂
  

Reading List

1. "Medical Device Design and Regulation" by Carl T. DeMarco
   ISBN: 289344119-07-01T09:34:08.
   Publisher: Quality Press

RequiredMTR5105: Clinical Evaluation

MTR5105: Clinical Evaluation

Semester 2 | Credits: 5

This module aims to provide students with a detailed knowledge and understanding of when a clinical investigation is necessary and the regulatory processes involved in such an evaluation.
(Language of instruction: English)

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of the key clinical terms, types of studies, key clinical requirements and associated standards.
2. Source and interpret, regulations, standards and guidances on how clinical requirements in chosen markets are achieved
3. Critique the role of human factors studies and the impact of risk assessment.
4. Demonstrate an ability to prepare documentation associated with clinical evaluations.
5. Illustrate an ability to prepare regulatory submissions and clinical trial applications.
6. Formulate and communicate a competency in how to complete a full clinical evaluation plan, which will include objectives, methodology and literature searching processes and resulting clinical evaluation report including format, contents and layout
7. Prepare a clinical evaluation report.
8. Evaluate and assess a medical device to determine what, if any, clinical studies are required based upon a critical review of existing data for comparable medical devices. (consider strategy development, trial design and clinical evaluation context).

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  Deirdre Barrow 🖂
  
•  AIDAN TONER 🖂
  

Reading List

1. "Designing Clinical Research" by Stephen B Hulley
   ISBN: 1608318044.
   Publisher: Lippincott Williams & Wilkins
2. "Clinical epidemiology: How to Do Clinical Practice Research" by R. Brian Haynes... [et al.]
   ISBN: 0781745241.
   Publisher: Lippincott Williams & Wilkins

RequiredMTR5106: Quality Management Systems

MTR5106: Quality Management Systems

Semester 2 | Credits: 5

This module aims to provide students with a detailed knowledge and understanding of setting up a basic QMS and its implementation. It also aims to provide the students with a thorough understanding of the requirement for a quality management system and how to design this quality system under the CFR 820 or ISO13485 headings. It also aims to provide an overview of compliance assessment in relation to self assessment, external audits, vendor audits and demonstration of ongoing compliance, focusing on Part 11 compliance. The module is broken down as follows: ca 10% Intro/overview of QMS; 75% subsections of CFR 820; 15% Auditing and Part 11 compliance.
(Language of instruction: English)

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of how a medical device is designed, developed and manufactured in line with 20 CFR 820 and ISO13485.
2. Source and interpret ISO13485, CFR 820 and various other relevant standards
3. Understand and evaluate the key elements of 21 CFR 820 including but not exclusive to Quality Management System, Management responsibility, Resource Management, Product Realization, Measurement Analysis and Improvement
4. Demonstrate they have detailed knowledge and understanding of a QMS as specified by CFR820.
5. . Illustrate a thorough understanding of the underlying principles involved in regulatory compliance, the importance of auditing, best practice on dealing with auditors, Supplier and vendor approach, audit programme , preparation, audit management, dealing with regulatory agencies , audit response process, internal quality standards communication, effective line clearance, training, process flow charts, Part 11 compliance etc.
6. Conduct a systematic and independent examination of the effectiveness of a quality system or of its parts. Demonstrate an awareness of the importance of auditor training and the internal auditing programme and how to deal with unannounced audits.
7. Formulate and communicate an ability to implement quality and technical agreements.
8. Communicate they have a detailed knowledge and understanding of the required actions to release product post regulatory approval.
9. Demonstrate they have detailed knowledge and understanding of the regulatory role and requirements throughout the product development process.

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  Deirdre Barrow 🖂
  
•  AIDAN TONER 🖂
  

Reading List

1. "Medical device design and regulation" by Carl T. DeMarco.
   ISBN: 0873898168.
   Publisher: Milwaukee, Wis; ASQ Quality Press

Year 2 (60 Credits)

RequiredMTR5107: EU Medical Technology Regulatory Affairs Advanced

MTR5107: EU Medical Technology Regulatory Affairs Advanced

Semester 1 | Credits: 5

This module 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.
(Language of instruction: English)

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of how to manage change control from a EU regulatory perspective throughout the entire medical device lifecycle
2. Define the regulatory pathway for medical devices including complex combination or novel devices and devise appropriate regulatory strategies for a number of theoretical devices
3. Illustrate they have detailed knowledge and understanding of the submission types involved by completion of mock technical documentation from classification through to commercialization
4. Communicate detailed knowledge and understanding of CE Mark renewal process and Directive 98/79/EC
5. Demonstrate they have detailed knowledge and understanding of additional country specific requirements prior and post placement on market.
6. Source and interpret reimbursement requirements in each member state

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  DEMELZA LYNN 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  Una Canney 🖂
  

Reading List

1. "Medical Device Design and Regulation" by Carl T. DeMarco
   ISBN: 289344119-07-01T09:34:08.
   Publisher: Quality Press

RequiredMTR5108: US Medical Device Regulatory Affairs - Advanced

MTR5108: US Medical Device Regulatory Affairs - Advanced

Semester 1 | Credits: 5

This module aims to provide students with a detailed knowledge and understanding of the regulatory pathway for placing medical devices on the market in the US, the essential requirements of devices, submission types, change control and emerging technologies.
(Language of instruction: English)

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of the submission types involved by completion of mock submission documentation from classification through to commercialization.
2. Formulate and communicate judgements with regard to regulatory decision making process for devices and demonstrate ability to interact effectively with FDA agents
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.

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  DEMELZA LYNN 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  Deirdre Barrow 🖂
  
•  SERENA LAWLESS 🖂
  
•  AIDAN TONER 🖂
  

Reading List

1. "Medical Device Design and Regulation" by Carl T DeMarco
   ISBN: 289344119-07-01T09:34:08.
   Publisher: Quality Press
2. "FDA Regulatory Affairs" by edited by David Mantud, Douglas J. Pisano
   ISBN: 9781841849195.
   Publisher: London; Taylor & Francis Ltd

RequiredMTR5109: Risk Management, Labelling and Promotion

MTR5109: Risk Management, Labelling and Promotion

Semester 1 | Credits: 5

This module 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.
(Language of instruction: English)

Learning Outcomes

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.

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  DEMELZA LYNN 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  AIDAN TONER 🖂
  

Reading List

1. "The Failure of Risk Management: Why It's Broken and How to Fix It" by Douglas W. Hubbard
   ISBN: 13 9780470387.
   Publisher: Wiley

RequiredMTR5113: Medical Technology Regulatory Affairs DISSERTATION

MTR5113: Medical Technology Regulatory Affairs DISSERTATION

15 months long | Credits: 30

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
(Language of instruction: English)

Learning Outcomes

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.

Assessments

• Research (100%)

Teachers

•  TERRY SMITH 🖂
  
•  DEMELZA LYNN 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  Una Canney 🖂
  

RequiredMTR5110: Global Medical Technology Regulatory Affairs Part 2

MTR5110: Global Medical Technology Regulatory Affairs Part 2

Semester 2 | Credits: 5

This module 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, SE Asia (Taiwan/Korea). It explains the legislation applicable and guidelines available to medical device manufacturers. It also addresses emerging technologies.
(Language of instruction: English)

Learning Outcomes

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, SE 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 guidlines, directives 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 submission types involved by completion of mock technical documentation from classification through to commercialization.
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.

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  DEMELZA LYNN 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  Una Canney 🖂
  

Reading List

1. "Medical Device Design and Regulation" by Carl T DeMarco
   ISBN: 289344119-07-01T09:34:08.
   Publisher: Quality Press

RequiredMTR5111: Design Assurance, Sterilisation and Biocompatability

MTR5111: Design Assurance, Sterilisation and Biocompatability

Semester 2 | Credits: 5

This module 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 also aims to provide a basic understanding of common biocompatibility testing methods and interpretation of results.
(Language of instruction: English)

Learning Outcomes

1. Demonstrate an ability to develop verifiable design inputs and understand the links to risk management activities
2. Design a test protocol including risk based acceptance criteria, sample sizes and use of appropriate statistical methods.
3. Develop a test report strategy and demonstrate ability to generate reports.
4. Critically assess the use of standard and non standard test reports.
5. Illustrate they have a detailed knowledge and understanding of the common sterilization techniques for medical devices.
6. Critique procedures and standards currently regulating medical device sterilization and validation requirements.
7. Source and interpret ISO10993 1 for evaluation of the biocompatibility of medical devices. Apply classification of the device as outlined in the standard
8. Demonstrate an understanding of the common biocompatibility testing methods and interpretation of the test results.
9. Formulate and communicate an understanding of the rationale and benefit of product characterization.
10. Evaluate sterilization methods under various headings to include packaging, products effects, costs etc.
11. Formulate and communicate an ability to generate biocompatibility reports to meet regulatory requirements

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  DEMELZA LYNN 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  AIDAN TONER 🖂
  

Reading List

1. "Biodesign: The Process of Innovating Medical Technologies" by Stefanos Zenios, Josh Makower, Paul Yock, Todd J. Brinton, Uday N. Kumar, Lyn Denend, Thomas M. Krummel
   ISBN: 0521517427.
   Publisher: Cambridge University Press
2. "Development of FDA-regulated medical products" by Elaine Whitmore.
   ISBN: 0873898338.
   Publisher: Milwaukee, Wis; ASQ Quality Press

RequiredMTR5112: Post Market Surveillance

MTR5112: Post Market Surveillance

Semester 2 | Credits: 5

This module aims to provide students with a detailed knowledge and understanding of post market requirements for medical devices. Specifically this module aims to develop the student’s 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.
(Language of instruction: English)

Learning Outcomes

1. Demonstrate they have detailed knowledge and understanding of global statutory reporting requirements including local interpretation and current expectations with particular emphasis on EU and US requirements.
2. Illustrate they have 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. Communicate a detailed knowledge and understanding of complaint management including assessment, evaluation and response to post market data.
4. Demonstrate they have detailed knowledge and understanding of risk management principles and requirements including the role of detailed risk assessment in the evaluation and response to post market data.
5. Illustrate they have detailed knowledge and understanding of requirements for all types of potential field actions including field safety corrective actions, advisory notices and recalls. This shall include an understanding of the critical components of effective field action management.
6. Understand the links between CER and risk management and other documentation to proactively incorporate these into routine post market surveillance activities.
7. Analyse and evaluate post market surveillance data within a risk management process to achieve a lower risk/better product, e.g. data from US FDA MAUDE (Manufacturer and user facility device experience) database.
8. Formulate and communicate a post marketing surveillance strategy which meets appropriate regulatory requirements.

Assessments

• Continuous Assessment (100%)

Teachers

•  TERRY SMITH 🖂
  
•  DEMELZA LYNN 🖂
  
•  OLIVIA MC DERMOTT 🖂
  
•  Deirdre Barrow 🖂
  
•  AIDAN TONER 🖂
  

Reading List

1. "FDA Regulatory Affairs" by edited by David Mantud, Douglas J. Pisano
   ISBN: 9781841849195.
   Publisher: London; Taylor & Francis Ltd