Medical Technology Regulatory Affairs - Galway
This programme offers a wholistic solution for participants to gain practical & theoretical understanding of regulatory affairs activities for the Medical Technology sector.
| Award Name | Higher Diploma (Level 8 NFQ) |
|---|---|
| NFQ Classification | Major |
| Awarding Body | Atlantic Technological University |
| NFQ Level | Level 8 NFQ |
| Award Name | NFQ Classification | Awarding Body | NFQ Level |
|---|---|---|---|
| Higher Diploma (Level 8 NFQ) | Major | Atlantic Technological University | Level 8 NFQ |
Duration
1 year, full-time, blended.
Study Hours
Generally, two evening lectures per week (2 hours each) followed by six (6) research & review self guided study hours maximum.
On-Campus Attendance
There will be at least one mandatory workshop in Semester 1 at ATU Galway City facilities for this programme.
This course will run subject to approved funding and sufficient student numbers.
Entry Requirements
Course participants must have at least a Level 8 qualification 240 credits (4 year hons degree) prior to acceptance onto this course or relevant technical experience (2-3 yrs) in the medical technology industry.
Recognition of Prior Learning: Yes
Further information
Start Date: September 2025.
Total fees: €9,000.
Flexible learning courses are popular, and they fill on a first come, first served basis. There are two major intake periods throughout the academic year, September and January.
For January start courses, applications typically open in October, and for September start courses, applications typically open in February. Closing dates for applications are listed on the individual course webpage.
This programme offers a wholistic solution for participants to gain practical & theoretical understanding of regulatory affairs activities for the Medical Technology sector. It supports the Medtech industry by ensuring that students are well practiced and educated on the specific regulations and associated application methods for global life science markets. It incorporates practical industry experience that will ensure students can immediately apply knowledge and competence. The aim of the programme is primarily intended to provide a qualification for graduates (employed/unemployed) to undertake or progress in a Medical Technology Regulatory affairs career.
Who should apply?
Quality & Engineering Technicians or Specialists in the Medical Device, IVD or Life Science sector. It is suitable for all Technical disciplines in the Medtech sector.
Modules:
Fundamentals in Regulatory Affairs - Introduction
Quality Management, Regulatory Strategy and Audit Practices
Design Controls, Risk Management and Clinical Studies for Medical Technology Industry
Medical Technology Regulations for the US Market
Medical Technology Regulations for the EU Market
Major Global Markets
Medical Device Safety Monitoring and Incident Reporting
A practical test of understanding of each module is carried out through ongoing assessment, team projects and class presentations. Module Advancement through attainment of required grade is mandatory.
Admissions: learn.galwaymayo@atu.ie