Overview
Regulatory Affairs for Medical Devices is offered by Trinity College Dublin. Understanding these rules, and their application, is of increasing relevance to ensuring that MedTech organisations meet their strategic goals and will be a key advantage in career development in the sector.
Key Facts
This programme will teach students about regulatory rules and principles, in addition to explaining the context in which these rules were developed, and the way in which they have been implemented in Europe. The course will be delivered on a part-time basis over two years has been designed to provide flexibility for students, who may already be working, to manage the challenge of balancing work, study and family responsibilities. Developed by regulatory specialists, in collaboration with leading clinical, academic and industry experts, the programme will be delivered by professionals who contributed to the negotiations and implementation of Medical Device Regulation (MDR) in Europe, in addition to experts who apply MDR in practice on a daily basis. This course is offered to graduates looking to develop a career in a MedTech organisation who would like to learn about European regulation of medical devices, and who may have an interest in becoming a person responsible for regulatory compliance.
Programme Structure
Courses include:
- Clinical Investigations
- Clinical Evaluation, Post-Market Assessment
- Biocompatibility and Medical Devices
- Risk Management and Medical Devices
- Quality Management and Conformity Assessment Pathways
- Qualification, Classification, Borderline Products and Device Traceability
- Preparing A Clinical Development Plan for a Novel Active Implanted Medical Device
- Regulatory Policy
- Research Project And Dissertation
Key information
Duration
- Part-time
- 24 months
Start dates & application deadlines
- Starting
- Apply before
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Language
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Credits
Delivered
Campus Location
- Dublin, Ireland
Disciplines
Medicine View 60 other Masters in Medicine in IrelandWhat students do after studying
Academic requirements
English requirements
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Other requirements
General requirements
- Applicants are expected to have an Honours Bachelor's degree, ideally at 2.1 level or above, in one of the following disciplines: pharmacy, medicine, allied health professions, biomedical engineering, biology, law. Other disciplines may also be considered as suitable on a case-by-case basis, and an interview may be offered to assess suitability.
- Applicants will ideally have some experience in MedTech development, manufacturing or regulation; however applicants with other relevant experience are welcome to apply.
Student Insurance via Studyportals Partner
Make sure to cover your health, travel, and stay while studying abroad. Even global coverages can miss important items like Additional medical costs, Repatriation, Liability etc. Make sure your student insurance covers your needs.
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Remember, countries and universities may have specific insurance requirements. To learn more about how student insurance work at Trinity College Dublin and/or in Ireland, please visit Student Insurance Portal.
Tuition Fees
-
International Applies to you
Applies to youNon-residents13770 EUR / year≈ 13770 EUR / year -
EU/EEA Applies to you
Applies to youEU/EEA Nationals6550 EUR / year≈ 6550 EUR / year
Living costs
Dublin
The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.
Funding
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Scholarships Information
Below you will find Master's scholarship opportunities for Regulatory Affairs for Medical Devices.
Available Scholarships
You are eligible to apply for these scholarships but a selection process will still be applied by the provider.
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