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Medical Technology Regulatory Affairs and Quality (Higher Diploma)

Higher Diploma (Medical Technology Regulatory Affairs and Quality)

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Course Overview

The Level 8 Higher Diploma in Medical Technologies Regulatory Affairs and Quality provides students with an introduction to the core elements of the product development lifecycle and the associated role of a Medical Technology Regulatory Affairs and/or Quality professional.  The programme ensures that students acquire a good, fundamental understanding of all applicable regulations and skills to address the ever-changing environment of Medical Technologies Regulatory Affairs and Quality.

The Higher Diploma in Medical Technology Regulatory Affairs and Quality programme has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by University of Galway and IT Sligo, in conjunction with external professionals and industry practitioners who have all the required expertise, knowledge, skills and experience to deliver the education and training required to the highest international standards.

The course will link the existing regulations to regulatory requirements and how those requirements are executed across the medical device lifecycle, for example; how to develop technical documentation for regulatory submissions (regulatory affairs professionals), how to perform vigilance post market surveillance requirements (Vigilance specialist), core quality management standards and requirements (QA or Compliance Specialist) and testing requirements to demonstrate safety and efficacy of a medical device (R&D Engineer). 

Regulatory Affairs and Quality personnel within the medical technology products sector are 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 healthcare system.  Given the evolving nature of international regulations regulatory affairs and quality assurance professionals must continually grow their knowledge and skills to be effective and to advance in their careers. This course will ensure the development and enhancement of those skills.  

 The programme aims are to: 

  • Provide participants with a fundamental grounding in medical device regulatory and quality requirements.
  •  Provide necessary training to convert personnel with life sciences qualifications to transition into specialist roles in medical technology quality assurance and/or regulatory affairs functions and upskill medical technology professionals in the regulatory framework in their existing roles. 
  •  To ensure that participants have sufficient skills and knowledge to employ a fundamental level of data analysing, sythesising, summarising and writing skills in a regulatory environment
  •  Foster participants’ intellectual development and develop skills to work and communicate effectively through various media
  •  To ensure participants have the skills and ability to function within, and adapt to, a changing technical work environment and evolving regulatory frameworks
  •  To ensure the participants can provide appropriate input and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world.

The course will enable Regulatory Affairs and Quality Assurance personnel in the Medical Technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of Regulatory Affairs and Quality Assurance. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits. Upon successful completion of the programme, participants receive an NFQ Level 8 Higher Diploma award of 60 credits.

Scholarships Available
Find out about our Postgraduate Scholarships here.

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You may also be interested in one of our other Life and Biomedical Sciences postgraduate programmes.

Applications and Selections

To find out how to apply for the course please contact olivia.mcdermott@universityofgalway.ie or butler.mary@itsligo.ie.

Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme.  Applications from candidates who hold a Level 7 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. 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 e.g. IELTS English language proficiency of 6.5 (with no band less than 6.0 in each element of the test) or equivalent. 

International students, whose first language is not English, will also need to provide evidence of their oral communication skills at interview. In addition to demonstrating their English language competency, they will need to provide evidence of having relevant experience in research (laboratory and/or computational desk based research) at undergraduate level or post-graduation.

Who Teaches this Course

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

The staff associated with the programme development and delivery include:

  • Ms Mary Butler (IT Sligo)—Co-Director
  • Ms Deidre Barrow (Med Tech Regulatory Affairs Consultant)—Lecturer
  • Dr Olivia McDermott (University of Galway)— Lecturer
  • Dr Sandra Ganly (University of Galway)—Lecturer
  • Dr Stephen Daly (IT Sligo)—Lecturer
  • Dr Ailish Breen (IT Sligo)—Lecturer
  • Dr Mary Garvey (IT Sligo)—Lecturer
  • Dr Yvonne Lang  (IT Sligo) – Lecturer
  • Dr Tom  Patton (IT Sligo)
  • Dr Colin Fowley (IT Sligo)

Requirements and Assessment

Assessment of students will be through continuous assessment of each module, which will include written assignments, team-based assignments, and open-book exams using multiple choices, matching questions as well as short and long answer questions.  

Key Facts

Entry Requirements

Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme.  Applications from candidates who hold a Level 7 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. 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, i.e., IELTS English language proficiency of 6.5 (with no band less than 6.0 in each element of the test) or equivalent.

International students, whose first language is not English, will also need to provide evidence of their oral communication skills at interview. In addition to demonstrating their English language competency, they will need to provide evidence of having relevant experience in research (laboratory and/or computational desk based research) at undergraduate level or post-graduation.

Additional Requirements

Recognition of Prior Learning (RPL)

Duration

2 years, part-time online distance learning (100% online)

Next start date

September 2024

A Level Grades ()

Average intake

30

QQI/FET FETAC Entry Routes

Closing Date

No set closing date. Offers made on a continuous basis.

NFQ level

Level 8

Mode of study

ECTS weighting

60

Award

CAO

Course code

HDIP-MTD

Course Outline

The Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality is a two year part-time programme (60 credits). The programme is made available online using a combination of distance-learning / e-learning technologies, with some optional workshops. The educational elements are provided by University of Galway and Institute of Technology Sligo staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.

The programme consists of 12 modules, each worth 5 ECTS. The programme is delivered over four semesters (two academic years). Three modules are delivered per semester.

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. 

Year 1 

Semester 1 Modules (each module is 5 ECTS)

  1. Introduction to Quality Management Systems
  2. Fundamentals of EU Medical Device Regulations
  3. Auditing and Compliance 

Semester 2 Modules (each module is 5 ECTS)

  1. Fundamentals of US Medical Device Regulations
  2. Risk Assessment
  3. Validation and Calibration 

Year 2 

Semester 3 Modules (each module is 5 ECTS)

  1. Fundamentals of Global Medical Device Regulations
  2. Sterilisation & Biocompatability
  3. Operations Management. and GMP 

Semester 4 Modules (each module is 5 ECTS)

  1. Fundamentals of Medical Device Clinical Trials
  2. Introduction to Market Vigilance & Labelling
  3. Technical Report Writing

Curriculum Information

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.
Module
An examinable portion of a subject or course, for which you attend lectures and/or tutorials and carry out assignments. E.g. Algebra and Calculus could be modules within the subject Mathematics. Each module has a unique module code eg. MA140.
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)

RequiredMTR1101: Introduction to Quality Management Systems


Semester 1 | Credits: 5

This module aims to provide students with an introduction to Quality Management and an understanding of setting up a basic QMS and its implementation. It also aims to provide the students with an understanding of the requirement for a quality management system and how to design this quality system under the 21 CFR 820 or ISO13485 headings. The principles of quality management and quality systems in both production and GMP environments will be discussed. The following quality management principles and concepts will be introduced; Quality Management in a digital age, Quality 4.0 and the future of Quality management; statistical process control; the measurement and benchmarking of quality; tools and techniques for quality improvement; organizational and teamwork requirements for quality implementation; strategic issues in quality management and finally current developments in quality management.
(Language of instruction: English)

Learning Outcomes
  1. Describe the evolution of Quality Management Systems including the Future of Quality; Quality 4.0
  2. Describe a basic QMS and its components as well as Quality Management systems in a digital age
  3. Explain the application and requirements of a QMS as prescribed by 21CFR 820 (and integration of ISO 13485:2016 as consensus standard) and with EN ISO 13485:2016
  4. Explain the application and requirements of ongoing and future regulatory body legislative programs aligned with meeting industry needs for Quality 4.0
  5. Describe the integration of operational excellence methods; Lean and Six Sigma with quality to implement and achieve continuous quality improvement in the MedTech industry
  6. Describe skillset for the future quality engineers in the smart factory; the barriers, enablers, components, and smart digital technologies involved in Quality 4.0 deployment
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Quality Management for Organizational Excellence" by David L. Goetsch, University of West Florida and Oskaloosa-Walton
    ISBN: 9780133791853.
    Publisher: Pearson
  2. "Quality Management for Organizational Excellence: Introduction to Total Quality" by David L Goetsch
    ISBN: ISBN-13.
    Publisher: Pearson
The above information outlines module MTR1101: "Introduction to Quality Management Systems " and is valid from 2021 onwards.
Note: Module offerings and details may be subject to change.

RequiredMTR1102: Fundamentals of EU Medical Device Regulations


Semester 1 | Credits: 5

This module aims to provide students with an introduction to and a fundamental understanding of current and upcoming EU legislation as it applies to medical devices and to provide students with an understanding of the EU classification system and potential regulatory pathways for placing medical devices on the market in the EU. It also aims to provide the students with an understanding of the utilisation of standards and guidance documents (MEDDEVs, NBOGs and NBMEDS).
(Language of instruction: English)

Learning Outcomes
  1. Describe the evolution of current legislation and reasons for upcoming revised legislation
  2. Classify a medical device under EU requirements
  3. Analyse and navigate key guidance documents
  4. Define an appropriate regulatory pathway for a number of device classifications and associated conformity assessment routes
  5. Make change control assessments for common change types
  6. Identify the key documents required in technical documentation to support an EU regulatory submission
  7. Analyse the role and expectations of the manufacturer, authorized representative, notified body and Competent Authority
  8. Describe the basics of ISO 13485:2016, PMS Requirements and Vigilance Requirements
Assessments
  • Continuous Assessment (100%)
Teachers
The above information outlines module MTR1102: "Fundamentals of EU Medical Device Regulations" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

RequiredMTR1103: Auditing and Compliance


Semester 1 | Credits: 5

This module introduces the regulatory requirement for GMP & compliance auditing, its benefits to an organisation and the tools required by an effective auditor. In addition, it also introduces corrective and preventive action, non conformance reporting and ongoing compliance.
(Language of instruction: English)

Learning Outcomes
  1. Interpret and explain the relevance of auditing as a means of monitoring the production of safe and effective medtech products in a GMP environment
  2. Describe the various auditing techniques available and the regulatory basis for GMP/compliance auditing
  3. Source, interpret and apply GMP principles to different case scenarios
  4. Roleplay and participate in a multidisciplinary team of auditors within a GMP environment
  5. Critique the performance of a systematic and independent examination of the effectiveness of a quality system
  6. Identify, assess and analyse breaches of GMP and recommend appropriate corrective and preventive actions
  7. Evaluate non-conformance statements and understand the non conformance management process
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Medical device design and regulation" by Carl T. DeMarco.
    ISBN: 9780873898164.
    Publisher: Milwaukee, Wis; ASQ Quality Press
  2. "Quality audits for improved performance" by Dennis.R.Arter
    ISBN: 978-0-87389-5.
    Publisher: ASQ
The above information outlines module MTR1103: "Auditing and Compliance" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

RequiredMTR1104: Fundamentals of US Medical Device Regulations


Semester 2 | Credits: 5

This module aims to provide students with an introduction to and a fundamental understanding of current US legislation as it applies to medical devices and to provide students with an understanding of the US FDA classification system and potential regulatory pathways for placing medical devices on the market in the US. It also aims to provide the students with an understanding of the utilisation of standards and FDA guidance documents.
(Language of instruction: English)

Learning Outcomes
  1. Describe the evolution of current legislation
  2. Classify a medical device under US requirements
  3. Analyse and navigate key guidance documents and consensus standards and key FDA medical device databases
  4. Define an appropriate regulatory pathway for a number of device classifications
  5. Make change control assessments for common change types
  6. Identify the key documents required in technical documentation to support a US regulatory submission
  7. Evaluate how to interact effectively with FDA agents/reviewers
  8. Evaluate the basics of US QSRs, PMS Requirements and Vigilance Requirements and navigate the US FDA MAUDE database
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "FDA Regulatory Affairs" by Mantus, Pisano
    ISBN: 9781841849201.
    Publisher: CRC Press
  2. "Medical device design and regulation" by Carl T. DeMarco.
    ISBN: 9780873898164.
    Publisher: Milwaukee, Wis; ASQ Quality Press
The above information outlines module MTR1104: "Fundamentals of US Medical Device Regulations" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

RequiredMTR1105: Risk Assessment


Semester 2 | Credits: 5

This module will enable students to understand the role of Risk assessment through the design process and product lifecycle. Students will also gain an understanding of the concept of Risk Management and be able to describe a basic Risk management system and its components as well as the application and requirements of Design & Risk Management under 21CFR 820
(Language of instruction: English)

Learning Outcomes
  1. Analyse the concept of Risk Management
  2. Describe a basic Risk management system and its components
  3. Explain the application and requirements of Design & Risk Management under 21CFR 820
  4. Explain the application and requirements of Design & Risk Management under ISO14971
  5. Describe the risk management tools used to help manage risk in the product lifecycle
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Strategy and Risk Management : An Integrated Practical Approach" by Ron Rael
    ISBN: 9781940235219.
    Publisher: John Wiley & Sons Inc.
The above information outlines module MTR1105: "Risk Assessment" and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.

RequiredMTR1106: Validation and Calibration


Semester 2 | Credits: 5

This module introduces the regulatory requirement for calibration and validation within a GMP environment, their benefits to an organisation and the tools required for effective implementation This module will prepare students to undertake different validation roles and will equip the student to complete many validation activities within their organisation. The impetus for the development of this module has emerged from industry needs and the course content has been designed to meet this industry need. This module covers the core aspects of interpreting and/or setting quality characteristics and their verification through appropriate calibrated Inspection, Measurement and Testing processes. The module traces the metrological requirements from quality characteristics through instrument selection, evaluation and on-going calibration so that the student is fully aware of the purpose and operation of a good measurement management system.
(Language of instruction: English)

Learning Outcomes
  1. Interpret and explain the relevance of calibration within a GMP and Quality Assurance environment.
  2. Describe the various metrological requirements from quality characteristics through instrument selection, evaluation and ongoing calibration
  3. Outline the properties of a good measurement management system and how it links to validation
  4. Interpret the key elements in a systematic approach to validation with an emphasis on medical device manufacture
  5. Critique risk analysis and evaluation and how it relates validation 6. Source and interpret the industry standard guidelines in use for validation within a GMP environment.
  6. Source and interpret the industry standard guidelines in use for validation within a GMP environment.
  7. Outline elements of validation documentation and understand the regulatory requirements and the use of risk management tools in making regulatory decisions.
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "The GAMP Guide for Validation of Automated Systems" by n/a
    ISBN: 1931879613.
The above information outlines module MTR1106: "Validation and Calibration" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

Year 2 (30 Credits)

RequiredMTR1107: Fundamentals of Global Medical Device Regulations


Semester 1 | Credits: 5

This module aims to provide students with an introduction to and a fundamental understanding of applicable legislation to medical devices in key markets outside EU and US such as Canada, Australia, Japan and emerging markets. The module will provide students with an understanding of the semantics of each classification system and potential regulatory pathways for placing medical devices on the market in global markets. The module will outline and the legal basis for the use of a Notary Public and documents such as Certs of Free Sale, legalised and consularised documentation.
(Language of instruction: English)

Learning Outcomes
  1. Explain the reason for use of The Hague Convention, Notary Public, Legalisation and Consularisation of documentation
  2. Demonstrate an understanding of the basics of applicable legislation in each market
  3. Classify a medical device under in each market
  4. Demonstrate an understanding of each regulatory system such that one can facilitate regulatory submissions in each market
  5. Navigate basic change control principles for each market
  6. Demonstrate an understanding of the outline of the STED document and the function of the IMDRF
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Handbook of Medical Device Regulatory Affairs in Asia" by Pan Stanford
    ISBN: ISBN 10.
    Publisher: Pan Stanford
  2. "Medical Device Regulatory Practices: An International Perspective" by Val Theisz
    ISBN: ISBN 10.
    Publisher: Pan Stanford
The above information outlines module MTR1107: "Fundamentals of Global Medical Device Regulations" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

RequiredMTR1108: Sterilisation and Biocompatability


Semester 1 | Credits: 5

The aim of this module is to give students an understanding of the importance of sterilisation of medical devices in order to insure there is no risk of microbial contamination following use. The most commonly used sterilisation methods will be discussed, detailing the theory behind the method, advantages and disadvantages and applications of each. Students will also learn about disease causing pathogens, virulence factors and associated risks to public health. This module also introduces the students to biocompatibility testing of medical devices according to the ISO guidelines, highlighting the aims and requirements for a number of assays. An overview of human anatomy, toxicology and pharmacology will also be given to ensure students are aware of the importance and risks associated with poor biocompatibility of medical devices i.e. patient morbidity, immune system response and associated diseases. Therefore, students will obtain a good understanding of the toxicology and pharmacology aspects relevant to human toxicity following exposure to medical devices and/or leachates e.g. liver and kidney function in metabolism and elimination of toxic materials. Students will gain knowledge and experience (via CA material) in all aspects of sterilisation, sterility testing (SAL, bio burden etc) and biocompatibility of medical devices according to the ISO guidelines. This module aims to develop the students understanding of experimental procedures allowing them to conduct experiments and analyze data.
(Language of instruction: English)

Learning Outcomes
  1. Explain and predict the risks associated with medical device contamination, routes of contamination, microbial pathogenicity and prevention methods.
  2. Summarise sterilisation of medical devices, requirements, application of sterilisation methods to specific materials and sterility testing methods.
  3. Evaluate the risks associated with medical device materials from a disease risk and organ biocompatibility view.
  4. Demonstrate an understanding of toxicity testing incorporating both target organ and systemic endpoints.
  5. Show an ability to interpret biocompatibility testing data generated following testing and to use this to determine a materials level of compatibility.
  6. Demonstrate an understanding of the requirements (ISO) to be met and adhered to when ensuring a medical device is both suitably sterilised and biocompatible pre and post-sterilisation.
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Regulatory Affairs for Biomaterials and Medical Devices" by n/a
    ISBN: ISBN10ISBN13.
    Publisher: Woodhead Publishing
  2. "Biomaterials Science, Third Edition" by Buddy D. Ratner, Allan S. Hoffman, Frederick J. Schoen, Jack E. Lemons
    ISBN: 9780123746269.
    Publisher: Academic Press
  3. "Immunology: With STUDENT CONSULT Online Access, 8e" by David Male MA PhD, Jonathan Brostoff MA DM DSc(Med) FRCP FRCPath, David Roth MD PhD, Ivan Roitt DSc HonFRCP FRCPath FRS
    ISBN: 9780323080583.
    Publisher: Saunders
The above information outlines module MTR1108: "Sterilisation and Biocompatability" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

RequiredMTR1109: Operations Management & GMP


Semester 1 | Credits: 5

This module aims to provide students with an introduction to current and future knowledge of strategic operations including Industry 4.0, MedTech 4.0, and Smart Operations engineering and management in the context of a GMP environment.
(Language of instruction: English)

Learning Outcomes
  1. Outline Manufacturing & Operations Engineering functions and the importance of Operations Engineering Strategy in Product and Service Design, Process Technology, and Quality Control.
  2. Recognise and Define GMP, Manufacturing types and layouts and describe how to balance a line.
  3. Explain Purchasing, Logistics and Supply Chain Management concepts as well as Planning and Inventory control in the context of a GMP organisation.
  4. Explain Industry 4.0 in the context of operations engineering and MedTech 4.0; definition, technologies, enablers, barriers; benefits; and strategies for implementation in the context of a GMP organization.
  5. Summarise and explain Operational Excellence; Lean philosophy, Six Sigma; Agile Project Planning in the context of GMP Operations Management.
  6. Illustrate data analytics; tools and techniques and calculations to demonstrate understanding and application of the learning outcomes.
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Global Logistics and Supply Chain Management" by John Mangan
    ISBN: 1119117828.
    Publisher: Wiley
The above information outlines module MTR1109: "Operations Management & GMP " and is valid from 2021 onwards.
Note: Module offerings and details may be subject to change.

RequiredMTR1110: Fundamentals of Medical Device Clinical Trials


Semester 2 | Credits: 5

This module aims to provide students with an introduction to and a fundamental understanding of how clinical trials are designed to address questions regarding the safety and effectiveness of medical devices. This course addresses the practical issues in the design of medical device trials and protocol development, as well as broader issues related to clinical trial design and interaction between the regulators and sponsors.
(Language of instruction: English)

Learning Outcomes
  1. Explain the reason for current regulations regarding the conduct of clinical trials
  2. Confirm and explain understanding of FDA IDE regulations.
  3. Relate understanding of ISO 14155 requirements
  4. Summarise the key roles of individuals involved in clinical research
  5. Identify the key types of clinical trials
  6. Describe the key elements of clinical trial design and ICH GCP
  7. Relate Ethical principles and human subject protection and Informed Consent requirements
  8. Explain the impact of MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and relate some of the most significant changes
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Clinical Evaluation of Medical Devices" by Karen M. Becker
    ISBN: ISBN 10.
    Publisher: Humana Press
  2. "The Design and Management of Medical Device Clinical Trials: Strategies and Challenges" by Salah M. Abdel aleem
    ISBN: ISBN 10.
    Publisher: Wiley
The above information outlines module MTR1110: "Fundamentals of Medical Device Clinical Trials " and is valid from 2020 onwards.
Note: Module offerings and details may be subject to change.

RequiredMTR1111: Introduction to Market Vigilance and Labelling


Semester 2 | Credits: 5

This module introduces the students to labelling and post market requirements for medical devices. It aims to develop the students understanding of what a post market surveillance plan is and how to collect, analyse and respond to data on device safety and performance after market approval. It also aims to provide students with knowledge of the labelling requirements for medical devices.
(Language of instruction: English)

Learning Outcomes
  1. Interpret and explain global statutory reporting requirements including local interpretation and current expectations.
  2. Appraise post market surveillance requirements and requirement for development of a post market surveillance plan.
  3. Evaluate the components of a complaint management including assessment, evaluation and response to post market data.
  4. Demonstrate knowledge of the requirements for all types of potential field actions including field safety corrective actions, advisory notices and recalls.
  5. Evaluate strategies for post market surveillance of medical devices in the US and EU.
  6. Communicate an 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, e labelling.
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Medical device design and regulation" by Carl T. DeMarco.
    ISBN: 0873898168.
    Publisher: Milwaukee, Wis; ASQ Quality Press
  2. "Medical Devices: Regulations, Standards and Practices" by Seeram Ramakrishna
    ISBN: ISBN 10.
    Publisher: Woodhead Publishing
  3. "FDA Regulatory Affairs" by edited by David Mantud, Douglas J. Pisano
    ISBN: 9781841849195.
    Publisher: London; Taylor & Francis Ltd
The above information outlines module MTR1111: "Introduction to Market Vigilance and Labelling " and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

RequiredMTR1112: Technical Report Writing


Semester 2 | Credits: 5

This module will enable students to acquire the research and study skills necessary for successful completion of the Higher Diploma in MedTech Regulatory Affairs and Quality. The module will help students construct technical reports and will develop skills in clear use of language and grammar to ensure compliance. The module will help students develop skills in literature searching, referencing and critiquing peer reviewed literature including data analysis. The module will help students connect the importance of good report writing skills to the workplace and wider society.
(Language of instruction: English)

Learning Outcomes
  1. Demonstrate good writing style in a technical document with correct referencing style.
  2. Conduct and synthesise an academic literature search relevant to a proposed topic.
  3. Present research findings in a critically reflective manner which acknowledges the limitations of the research methods and knowledge produced.
  4. Critically evaluate a technical document in area such as compliance.
  5. Compare methods for data analysis and the presentation of results and compare different methods when presenting different results.
  6. Clearly demonstrate an awareness of relevance to industry/workplace and societal impact.
Assessments
  • Continuous Assessment (100%)
Teachers
Reading List
  1. "Technical Report Writing Today" by Daniel G. Riordan
    ISBN: ISBN 10.
    Publisher: Cengage Learning
  2. "Chambers Good Writing Guide: Practical Advice for Better Writing" by Ian Brookes
    ISBN: ISBN 10.
    Publisher: Chambers Harrap Publishers
  3. "The MIT guide to science and engineering communication" by James G. Paradis and Muriel L. Zimmerman
    ISBN: 0262661276.
    Publisher: MIT Press
The above information outlines module MTR1112: "Technical Report Writing" and is valid from 2018 onwards.
Note: Module offerings and details may be subject to change.

Further Education

Following completion of the Higher Diploma (60 credits) students are eligible to apply to undertake the MSc in Medical Technologies Regulatory Affairs, a part-time distance learning Level 9 programme jointly delivered by University of Galway and IT Sligo.

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 global Medical Technology industry sector. It has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a taskforce comprised of regulatory experts from industry and industry practitioners.

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 ensuring 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 are involved to some degree in bridging the gap between regulatory-related functions and organisation and business activities.  

The Irish MedTech Association (IMA) asked senior MedTech industry executives to identify the current number of employees required to meet current skills demand, as well as forecasted number of employees required in MedTech organisations up to 2020. The IMA report (2017) has estimated that 4,000 additional Medical Technologies jobs will be added by 2020, with a 43% increase in staff numbers in the regulatory affairs functions and 17% in Quality roles. Over 30,000 people are employed in the highly successful and growing Irish Medical Technology industry sector, representing one of the leading global hubs of MedTech industries.

Who’s Suited to This Course

Learning Outcomes

Transferable Skills Employers Value

Work Placement

Study Abroad

Related Student Organisations

Course Fees

Fees: EU

€4,500 p.a. 2024/25

Fees: Tuition

€4,444 p.a. 2024/25

Fees: Student levy

€56 p.a. 2024/25

Fees: Non EU

€8,000 p.a. 2024/25


For information on possible fee support available through Next Level Skillnet to eligible applicants, please contact butler.mary@itsligo.ie or olivia.mcdermott@universityofgalway.ie.

Note: To be eligible for EU (as opposed to the higher Non-EU) fee rates, applicants must qualify through Nationality or Residency.  For further information visit https://www.universityofgalway.ie/student-fees/international/

Find out More

Course Co-Director:
Ms Mary Butler
E: butler.mary@itsligo.ie

Lecturer and Quality and Regulatory Affairs Expert: 
Dr Olivia McDermott
E: olivia.mcdermott@universityofgalway.ie

Lecturer and Medical Technology Regulatory Affairs consultant:
Deirdre Barrow
E: Barrow.Deirdre@itsligo.ie   

 

 

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