Program Overview

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.

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.
• Duration: 2 years, part-time online distance learning (100% online)
• Next Start Date: September 2026
• Average Intake: 30
• NFQ Level: Level 8
• Mode of Study: Part-time online
• ECTS Weighting: 60
• Award: Higher Diploma

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 Atlantic Technological University 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.

Year 1

• Semester 1 Modules:
  1. Introduction to Quality Management Systems
  2. Fundamentals of EU Medical Device Regulations
  3. Auditing and Compliance
• Semester 2 Modules:
  1. Fundamentals of US Medical Device Regulations
  2. Risk Assessment
  3. Validation and Calibration

Year 2

• Semester 3 Modules:
  1. Fundamentals of Global Medical Device Regulations
  2. Sterilisation & Biocompatibility
  3. Operations Management & GMP
• Semester 4 Modules:
  1. Fundamentals of Medical Device Clinical Trials
  2. Introduction to Market Vigilance & Labelling
  3. Technical Report Writing

Module Details

MTR1101: Introduction to Quality Management Systems

• 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%)
• Reading List:
  1. "Quality Management for Organizational Excellence" by David L. Goetsch, University of West Florida and Oskaloosa-Walton
  2. "Quality Management for Organizational Excellence: Introduction to Total Quality" by David L Goetsch

MTR1102: Fundamentals of EU Medical Device Regulations

• 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%)
• Reading List:
  1. "Medical device design and regulation" by Carl T. DeMarco
  2. "Quality audits for improved performance" by Dennis.R.Arter

MTR1103: Auditing and Compliance

• 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%)
• Reading List:
  1. "Medical device design and regulation" by Carl T. DeMarco
  2. "Quality audits for improved performance" by Dennis.R.Arter

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 ATU 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.
• Who's Suited to This Course: The programme is designed for individuals working in or aspiring to work in the medical technology industry, particularly those in regulatory affairs and quality assurance roles.

Course Fees

• Fees: EU: 4,500 p.a. 2025/26
• Fees: Tuition: 4,500 p.a. 2025/26
• Fees: Student Levy: 0
• Fees: Non-EU: Not specified

About University of Galway

Founded in 1845, University of Galway has earned international recognition as a research-led university with a commitment to top quality teaching.