Medical 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.
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
Total fees: €690
90% funding available from HCI, Springboard.
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.
What will I study?
Modules
Modules Overview:
Fundamentals in Regulatory Affairs
Quality Management System including compliance & regulatory auditing. Global Regulations & Medical Device Single Audit Programme (MDSAP)
Regulatory Affairs Business Strategy including Regulatory Intelligence, Pre-market & Postmarket responsibilities.
Clinical Evaluation masterclass series, Risk Management and Design Control process.
U.S. Regulations: How to do a 510k,PMA or DeNova
EU Regulations: MDR 2017/745 & IVDR 2017/746
Post Market Surveillance activities including Eudamed & Patient Safety requirements.
Special subject addressing SAMD: Software as a Medical Device & future expectations.
Examination & Assessment
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