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. 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.

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

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.

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.