Quality Training

Masters in Medical Technology Regulatory Affairs

Objectives

The global Medical Technology industry is a highly regulated industry, to ensure that medical devices are manufactured to the highest quality and safety standards. As such, Medical Technology companies have grown their regulatory affairs teams to meet the growing global regulatory demands. The Master's in Medical Technology Regulatory Affairs was developed specifically to enable regulatory affairs personnel in Medtech to understand the global regulatory landscape, and develop skills to address and prepare for the ever-changing environment of regulatory affairs. The programme design also develops complementary skill sets such as communication and research skills. The programme integrates legal principles, ethics and compliance issues.

Training takes place over typically two years, with two semesters per year. Participants will complete a dissertation during Year 2 of the programme.

Upon successful completion of the programme, participants receive an MSc award at NFQ Level 9.

Content Includes

EU Medical Technology Regulatory Affairs (introduction and advanced)

• US Medical Technology Regulatory Affairs (introduction and advanced)
• Technical Report Writing
• Global Medical Technology Regulatory Affairs
• Clinical Evaluation
• Quality Management System
• Risk Management, Labelling, and Promotion
• Design Assurance, Sterilisation and Biocompatability
• Post Market Surveillance

About the programme
The Irish Medtech Association Skillnet and contracting organisation, the Irish Medtech Association, the Ibec group that represents the Medical Technology sector and IT Sligo in collaboration with NUIG are delighted to present a new Masters in Medical Technology Regulatory Affairs to meet the growing requirements of Irish companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and content has been developed in conjunction with a taskforce comprising regulatory experts from Irish Medtech Association’s Regulatory and Quality Working Group.

Who should attend

Regulatory Affairs personnel in the Medical Technology industry
Entry requirements; Open to students who have obtained a Level 8 primary degree in a science/engineering subject related to the life sciences. Previous or current experience in regulatory affairs (minimum 2 years) may be taken into account in assessing entry qualifications for candidates with relevant Level 7 qualification with appropriate experience.

Qualification

NFQ Level 9 – 90 credits

Upcoming dates: