Course Overview

The Level 8 Certificate 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 Level 8 Certificate 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 NUI 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). 

 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. 
  • Foster participants’ intellectual development and develop skills to work and communicate effectively through various media

The Certificate course 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 from the six modules in one year.  Students must complete all six modules within six years, to obtain a Level 8 certificate award.

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.

Fees information

Springboard+ 2018.  Free & 90% Funded Level 8 Certificate Programme under the Springboard+ 2018 Initiative

The Level 8 Certificate has been approved as a Higher Education Authority Springboard course and Springboard is now open for applicants commencing programmes in September 2018.

Springboard Fees: €3,500

FREE for those classified as unemployed

 €350 (10%) Fee for employed participants

 To apply for the Certificate through Springboard please go to https://springboardcourses.ie/details/6180

Modular Fee EU: €900 per module—2018–19

 Fees: Non-EU: €8,000—2018–19

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.  For further information visit http://www.nuigalway.ie/student-fees/international/

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Applications and Selections

To find out how to apply for the course please contact terry.smith@nuigalway.ie or butler.mary@itsligo

Applications are made online via the NUI Galway Postgraduate Applications System

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

Step 1:  Ensure you are eligible—entry criteria

  • Students with a Level 7 or higher qualification in Science or Engineering are eligible for the proposed Level 8 programme.
  • Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of 5 years relevant medtech industrial experience in regulatory affairs or quality are eligible for the Level 8 programme.

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 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 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:

  • Prof. Terry Smith (NUI Galway)—Co-Director
  • Ms Mary Butler (IT Sligo)—Co-Director
  • Ms Deidre Barrow (Med Tech Regulatory Affairs Consultant)—Lecturer
  • Dr Olivia McDermott (NUI Galway)— Lecturer
  • Dr Sandra Ganly (NUI 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

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

  • Students with a Level 7 or higher qualification in Science or Engineering are eligible for the proposed Level 8 programme.
  • Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of 5 years relevant medtech industrial experience in regulatory affairs or quality are eligible for the Level 8 programme.

Additional Requirements

Duration

1 year part-time online course

Next start date

September 2019

A Level Grades ()

Average intake

40

Closing Date

15 August 2019

NFQ level

8

Mode of study

Part-time—online distance learning

ECTS weighting

30

Award

CAO

Course code

1MTQ2

Course Outline

  • The Level 8 Certificate in Medical Technology Regulatory Affairs and Quality is a one year part-time programme (30 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 NUI Galway and Institute of Technology Sligo staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.
  • The programme consists of six modules, each worth 5 ECTS. The programme is delivered over two semesters (one academic year). Three modules are delivered per semester.
  • Assessment of students is through continuous assessment of each module, including written assignments, e-tivities, problem solving, and online open-book exams using multiple choices, matching questions as well as short and long answer questions
  • The Certificate 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
  • Students undertaking the modular programme can select any individual module or combination of modules from the six modules in one year.  Students must complete all 6 modules within six years, to obtain a Level 8 certificate award.
  • 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 industry specialists and practitioners.

 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

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)

Optional MTR1101: Introduction to Quality Management Systems


Semester 1 | Credits: 5

This module aims to provide students with an introduction to and 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 CFR 820 or ISO13485 headings. The principles of quality management and quality systems and quality management in both production and GMP environment will be discussed. The following quality management principles and concepts will be introduced; statistical process control; the measurement and benchmarking of quality; tools and techniques for quality improvement; organisational 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
  2. Describe a basic QMS and its components
  3. Explain the application and requirements of a QMS as prescribed by 21CFR 820
  4. Explain the application and requirements of a QMS as prescribed by ISO13485:2016
  5. Describe the quality tools necessary to implement and achieve continuous quality improvement in the manufacturing
  6. Illustrate the audit requirements of a QMS and how to deal with auditors
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 2018 onwards.
Note: Module offerings and details may be subject to change.

Optional MTR1102: 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.

Optional MTR1104: 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.

Optional MTR1103: 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.

Optional MTR1105: Risk Assessment


15 months long | 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 2018 onwards.
Note: Module offerings and details may be subject to change.

Optional MTR1106: 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.

Further Education

Following completion of the one year Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 credits) students are eligible to continue for a second Year to complete a Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 credits). The Higher Diploma award ewill be available from September 2018.

Graduates with the Higher Diploma award will be eligible to apply to undertake the MSc. in Medical Technologies Regulatory Affairs, a part-time distance learning Level 9 programme jointly delivered by NUI 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

 

Work Placement

Study Abroad

Related Student Organisations

Course Fees

Fees: EU

€4,500 p.a. 2018/19

Fees: Tuition

€4,444 p.a. 2018/19

Fees: Student levy

€56 p.a. 2018/19

Fees: Non EU

€8,000 p.a. 2018/19

Springboard+ 2018.  Free & 90% Funded Level 8 Certificate Programme under the Springboard+ 2018 Initiative

The Level 8 Certificate has been approved as a Higher Education Authority Springboard course and Springboard is now open for applicants commencing programmes in September 2018. Springboard Fees: €3500

FREE for those classified as unemployed

€350 (10%) Fee for employed participants

To apply for the Certificate through Springboard please go to https://springboardcourses.ie/details/6180

Modular Fee EU:€900 per module—2018/19

Find out More

Course Co-Director:Prof. Terry SmithT: +353 91 492 022E: terry.smith@nuigalway.ie‌

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

Lecturer and Quality and Regulatory Affairs Expert:Dr Olivia McDermottE: Olivia.mcdermott@nuigalway.ie

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

 

 

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