Medical Technology Regulatory Affairs

ATU - Galway Campuses


Course Name Medical Technology Regulatory Affairs
Course Provider ATU - Galway Campuses
Alternative Provider(s) ATU - Atlantic Technological University
Course Code GA_SMRAG_L08
Course Type Postgraduate
Award NameNFQ ClassificationAwarding BodyNFQ Level
Higher Diploma (Level 8 NFQ)  More info... Major Atlantic Technological University Level 8 NFQ
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Attendance Options Full time, Daytime
Location (Districts) Galway City
Qualification Letters HDip
Enrolment and Start Dates Comment Start Date: September 2023. TBC.
Application Date

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Details on how to apply for Postgraduate Courses at ATU

Applications for programmes commencing in September 2023 are NOW OPEN.

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Duration 1 year full-time. Blended learning.
Link to Course Fee Web Page - Click Here
Entry Requirements

Expand+Course participants must have at least a level 8 qualification 240 credits (4 year hons degree) prior to acceptance onto this course. It is especially suitable for participants intending to work in regulatory affairs and quality related roles. .


Number of Places 30
Course Summary This course will provide a practical solution for participants to gain practical & theoretical understanding of regulatory affairs activities for the Medical Technology sector.
Course Content

The Higher Diploma Medical Technology Regulatory Affairs Professional will be delivered and accredited through Atlantic Technological University (ATU) Galway.

This programme is funded through the Irish Medtech Springboard.
It is a 60...

Subjects Taught Modules:
1. Fundamentals in Regulatory Affairs
2. Quality Management, Regulatory Strategy & Audit Practices
3. Design Controls, Risk Management & Clinical Studies for Medical Technology Industry
4. Medical Technology Regulations for the U.S. Market
5. Medical Technology Regulations for the EU Market
6. Major Global Markets
7. Medical Device Safety Monitoring and Incident Reporting
Careers or Further Progression

Expand+Job Opportunities
The knowledge gained in this programme is critical to all technical roles in the Life Science Sector. Research & Development Engineers along with Manufacturing Eng., Quality & Testing Specialists and Regulatory Professionals must...

Further Enquiries If you have any queries please email:
Name: Michelle Quain
Irish Medtech Springboard course co-ordinator
M: 087-1906802

Name: Carmel McGrath,
Course Director & Adjunct Lecturer ATU
Tel: 087-4185458
Course Web Page Web Page - Click Here