Medical Device Regulatory Affairs & Quality - Sligo
The course will enable Regulatory Affairs and Quality 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 everchanging global environment of regulatory affairs and quality.
| 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
2 years part-time. Delivery Method: Online.
On-Campus Attendance: One optional workshop each year which is an opportunity to meet lecturers and network with other students.
Entry Requirements
Level 7 qualification in a relevant area of Science, Engineering or Technology.
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, developed jointly by the University of Galway and ATU Sligo, has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles. The course will enable Regulatory Affairs and Quality 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 everchanging global environment of regulatory affairs and quality.
Modules
Introduction to Quality Management Systems
Fundamentals of EU Medical Device Regulations
Auditing and Compliance
Fundamentals of US Medical Device Regulations
Risk Management and Design Control
Validation and Calibration
Fundamentals of Global Medical Device Regulations
Sterilisation and Biocompatibility
Operations Management and GMP
Fundamentals of Medical Device Clinical Trials
Introduction to Market Vigilance and Labelling
Technical Report Writing
This programme is assessed via 100% continuous assessment.
Admissions: admissions.sligo@atu.ie
Student Advisor: Michelle Moore: Michelle.Moore@atu.ie