Course Overview

About the Programme

 The programme is offered as a two year part-time Level 9 MSc in Medical Technology Regulatory Affairs (90 credits). The programme is delivered online using a combination of distance-learning / e-learning technologies and face to face workshops for an overall blended learning approach. The programme consists of 12 modules, each worth 5 ECTS. Three modules are delivered per semester. A dissertation (30ECTS) is also carried out over Year 1 and year 2.  Assessment of students is through continuous assessment

The MSc programme is also available for students to undertake in a modular format. Students undertaking the modular programme can select any individual module or combination of modules in any year, up to a maximum of 3 modules per semester.  Students must complete all 12 taught modules and a research project within six years, to obtain an MSc degree.  Postgraduate Certificate and Diplomas are also available as exit degrees, based on the completion of 6 or 12 taught modules.  

 Programme objectives are to:

  • Produce graduates with the essential breadth and knowledge, skills and competencies required to work as a regulatory affairs professional in the Medical Technologies industry sector
  • Provide participants with professional skills and knowledge to conduct appropriate advanced data analysis and interpretation in a highly regulated environment
  • Enable participants to effectively communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public
  • Provide participants with the skills and ability to function within, and adapt to, a changing medical technologies environment with rapidly evolving regulatory frameworks
  • Prepare participants to provide strategic, tactical and operational direction and support to expedite the development and delivery of safe and effective healthcare products to the required regulatory standards

Applications and Selections

Applications are made online via The Postgraduate Applications Centre (PAC). 

In order to apply for this programme please complete all of the steps below:

Step 1:  Ensure you are eligible—entry criteria

  • Candidates should hold at least a Second Class Honours Level 8 primary degree in a relevant subject area in science or engineering
  • Prior medical technology industry experience in regulatory affairs will be considered a distinct advantage in assessing applications
  • Applications from candidates who hold a Second Class Honours Level 8 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and/or regulatory affairs will be considered
  • Applications will also be considered from candidates who hold a degree in a relevant subject area in science or engineering at Level 7, with at least two years’ medical technology industry experience in quality and/or regulatory affairs 
  • Candidate interviews may be used to assess candidates’ suitability for the programme
  • International students, whose first language is not English, will be required to prove their English competency through their school leaving examination or matriculation examination or by achieving the minimum standard in a recognised English language test

Step 2:  Have all of the supporting documentation in place

Visit our Supporting Documents website for document requirements for this course.

Step 3: Ensure that you meet the English Language requirements

All applicants, whose first language is not English must present one of the following qualifications in the English language and have no less than 6.5 in ANY component. NOTE: Language tests must be undertaken no more than two years prior to commencement of your programme at the University.

IELTS

TOEFL

Pearson PTE

6.5

88

61

6.5

88

61

6.5

88

61

 The NUI Galway TOEFL institution code is 8861.

Any PAC application queries should be emailed to postgradadmissions@nuigalway.ie 

Who Teaches this Course

The programme will be delivered by academic staff from NUI Galway and It Sligo, with expertise in Regulatory Affairs, with guest lectures and workshops involving Regulatory Affairs experts from the Medical technology industry sector. 

View programme team information here.

Requirements and Assessment

Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions.  The Research Project thesis will also be assessed. 

Key Facts

Entry Requirements

  • Candidates should hold at least a Second Class Honours Level 8 primary degree in a relevant subject area in science or engineering
  • Prior medical technology industry experience in regulatory affairs will be considered a distinct advantage in assessing applications
  • Applications from candidates who hold a Second Class Honours Level 8 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and/or regulatory affairs will be considered
  • Applications will also be considered from candidates who hold a degree in a relevant subject area in science or engineering at Level 7, with at least two years’ medical technology industry experience in quality and/or regulatory affairs 
  • Candidate interviews may be used to assess candidates’ suitability for the programme
  • International students, whose first language is not English, will be required to prove their English competency through their school leaving examination or matriculation examination or by achieving the minimum standard in a recognised English language test

Additional Requirements

Duration

2 years part-time

Next start date

September 2018

A Level Grades ()

Average intake

25

Closing Date

15 August 2018

Next start date

September 2018

NFQ level

9

Mode of study

Taught

ECTS weighting

90

Award

CAO

PAC code

GYS30 (part-time); GYS29 (part-time, modular)

Course Outline

  • The programme is offered as a two year part-time Level 9 MSc in Medical Technology Regulatory Affairs (90 credits)
  • The MSc. programme is also available for students to undertake in a modular format, enabling students to select any individual module or combination of modules in any year, up to a maximum of 3 modules per semester
  •  The module programme offering gives students the option to complete all 12 taught modules and a research project within six years to obtain an MSc. degree
  •  Post-graduate Certificate and Diploma awards are also available, based on the completion of 6 or 12 taught modules

The programme is being made available online using a combination of distance-learning/e-learning technologies and some face-to- face workshops for an overall blended learning approach. The educational elements is provided by the Institute of Technology, Sligo, and NUI Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners.

The programme consists of 12 modules, each of 5 ECTS, delivered over 2 Years (6 modules per year), and a research Project (30 ECTS), carried out over both years of the programme.

Modules for 2017-18

Curriculum information relates to the current academic year (in most cases).
Course and module offerings and details may be subject to change.

Glossary of Terms

Credits
You must earn a defined number of credits (aka ECTS) to complete each year of your course. You do this by taking all of its required modules as well as the correct number of optional modules to obtain that year's total number of credits.
Optional
A module you may choose to study.
Required
A module that you must study if you choose this course (or subject).
Semester
Most courses have 2 semesters (aka terms) per year.

Year 1 (30 Credits)

Required 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
Reading List
  1. "Medical Device Design and Regulation" by Carl T. DeMarco
    ISBN: 289344119-07-01T09:34:08.
    Publisher: Quality Press
The above information outlines module MTR5101: "EU Medical Device Regulatory Affairs - Introduction" and is valid from 2016 onwards.
Note: Module offerings and details may be subject to change.

Required 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
Reading List
  1. "Medical Device Design and Regulation" by Carl T. DeMarco
    ISBN: 289344119-07-01T09:34:08.
The above information outlines module MTR5102: "US Medical Device Regulatory Affairs - Introduction" and is valid from 2016 onwards.
Note: Module offerings and details may be subject to change.

Required 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
Reading List
  1. "Technical Report Writing Today" by Daniel G. Riordan
    ISBN: 33586117-06-30T09:34:08.
    Publisher: Houghton Mifflin Company
The above information outlines module MTR5103: "Technical Report Writing" and is valid from 2017 onwards.
Note: Module offerings and details may be subject to change.

Required 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
Reading List
  1. "Medical Device Design and Regulation" by Carl T. DeMarco
    ISBN: 289344119-07-01T09:34:08.
    Publisher: Quality Press
The above information outlines module MTR5104: "Global Medical Technology Regulatory Affairs Part 1 " and is valid from 2016 onwards.
Note: Module offerings and details may be subject to change.

Required 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
The above information outlines module MTR5105: "Clinical Evaluation" and is valid from 2016 onwards.
Note: Module offerings and details may be subject to change.

Required 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
The above information outlines module MTR5106: "Quality Management Systems" and is valid from 2017 onwards.
Note: Module offerings and details may be subject to change.

Year 2 (60 Credits)

Required 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
Reading List
  1. "Medical Device Design and Regulation" by Carl T. DeMarco
    ISBN: 289344119-07-01T09:34:08.
    Publisher: Quality Press
The above information outlines module MTR5107: "EU Medical Technology Regulatory Affairs Advanced" and is valid from 2016 onwards.
Note: Module offerings and details may be subject to change.

Required 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
Reading List
  1. "Medical Device Design and Regulation" by Carl T DeMarco
    ISBN: 289344119-07-01T09:34:08.
    Publisher: Quality Press
The above information outlines module MTR5108: "US Medical Device Regulatory Affairs - Advanced" and is valid from 2016 onwards.
Note: Module offerings and details may be subject to change.

Required 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
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
The above information outlines module MTR5109: "Risk Management, Labelling and Promotion" and is valid from 2017 onwards.
Note: Module offerings and details may be subject to change.

Required MTR5113: Medical Technology Regulatory Affairs DISSERTATION


Semester 1 and Semester 2 | 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
The above information outlines module MTR5113: "Medical Technology Regulatory Affairs DISSERTATION " and is valid from 2016 onwards.
Note: Module offerings and details may be subject to change.

Required 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
Reading List
  1. "Medical Device Design and Regulation" by Carl T DeMarco
    ISBN: 289344119-07-01T09:34:08.
    Publisher: Quality Press
The above information outlines module MTR5110: "Global Medical Technology Regulatory Affairs Part 2 " and is valid from 2016 onwards.
Note: Module offerings and details may be subject to change.

Required 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
Reading List
  1. "!!!Book Not Found" by n/a
    ISBN: 63035329-11-19T09:34:08.
  2. "Development of FDA Regulated Medical Products: A Translational Approach" by Elaine Whitmore
    ISBN: 289344289-06-29T09:34:08.
    Publisher: Quality Press
The above information outlines module MTR5111: "Design Assurance, Sterilisation and Biocompatability" and is valid from 2017 onwards.
Note: Module offerings and details may be subject to change.

Required 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
Reading List
  1. "FDA Regulatory Affairs" by Food and Drug Administration
    Publisher: CRC Press
The above information outlines module MTR5112: "Post Market Surveillance" and is valid from 2017 onwards.
Note: Module offerings and details may be subject to change.

Why Choose This Course?

Career Opportunities

This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the highly successful and growing Irish Medical Technology industry sector. 

The Irish Medical Devices Association (IMDA) states that the medical technology sector employs over 25,000 people, with 18 of the world’s top 25 medical technology companies maintaining a base in Ireland and a further 50% of the 300 Medtech companies being indigenous. The sector is expected to continue to grow as stated in December 2014 by the Director of the IMDA Sinead Keogh: "IMDA's latest survey shows that confidence within the sector is improving steadily with nearly half of companies more confident now than they were three months ago and nearly half planning to hire new staff. 

Regulatory Affairs within the medical technology products sector is a relatively young, multidimensional profession that is international in scope.  Operationally, a Regulatory Affairs professional is responsible for assuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and health care system.  Given the evolving nature of international regulations, a regulatory affairs professional must continually grow their knowledge and skills to be effective and to advance in their careers.

Regulatory professionals at all career and experience levels are involved in activities throughout the product lifecycle, and most are involved to some degree in bridging the gap between regulatory-related functions and organisation and business activities.  

Who’s Suited to This Course

Learning Outcomes

 

Work Placement

Study Abroad

Related Student Organisations

Course Fees

Fees: EU

€6,000 p.a. 2016/17

Fees: Tuition

€5,944 p.a. 2016/17

Fees: Student levy

€56 p.a. 2016/17

Fees: Non EU

€13,750 p.a. 2016/17
GYA29: €900 per module; research dissertation fee: €2,700. Information on funding opportunities & scholarships here. Policy re EU fees eligibility: www.nuigalway.ie/student-fees/international Note: In order to be eligible for EU (as opposed to the higher Non EU) fee rates, applicants must qualify through Nationality or Residency N.B. Eligibility for EU fee rates does NOT confer entitlement to ’free fees’. Note in particular the provisions regarding eligibility under: (1) Nationality and (2) Residence.

Find out More

Course Director:
Prof. Terry Smith

 

Pic

T: +353 91 492 022
Eterry.smith@nuigalway.ie

Course Director: 
Ms Mary Butler   

 

Institute of Technology, Sligo

Ebutler.mary@itsligo.ie

 

www.mscregaffairs.ie

View programme team information here.


What Our Students and Employers Say

Mark

Mark Fleming |   Managing Director, Fleming Medical

Our participation in the Masters in Medical Technology Regulatory Affairs has allowed our company to enter several new major export markets so we can confidently deal with each specific international market’s regulatory requirement.
Dymphna

Dymphna Power |   Quality and Regulatory Manager, Fleming Medical

The Masters is well worth pursuing, broadens knowledge with regard to regulatory compliance in European and Global markets.
Emily

Emily Kelly |   Healthcare Professional

The online MSc. in RA learning programme enabled me to gain a regulatory qualification, while balancing a full time job and a busy family life. Medical device manufacturers cannot work independently of RA. The course provided me with the knowledge and tools enabling me to make decisions from both a QM and RA perspective, taking into account every aspect of the medical device lifecycle from concept to post-market surveillance. In today’s market independent decision making can have severe repercussions for medical device manufacturers; this course provided the tools to navigate the regulatory landscape. The flexibility of on-line learning allowed for easy access to lectures, allowing completion of the course anywhere. Classes were interactive and the periodic workshops allowed for good interaction and team building among the group. Lecturers were very knowledgeable and helpful, providing constructive feedback on the application of the course material.
Brian

Brian Cullinan |   Director QA/RA, Siemens Healthcare Diagnostics

The regulatory environment is becoming increasingly complex and interconnected. Whilst regulations are harmonising, interpretation and implementation remain challenging. At Siemens Healthineers our QA/Regulatory professionals need to regularly refresh their knowledge as regulations evolve. The Masters in Medical Technology Regulatory Affairs provides a framework not only for acquiring the knowledge but also for building the expertise required to apply that knowledge practically and effectively. It’s the start of a career long learning experience, which enables us to develop world class regulatory professionals.

 

                      ‌