Regulatory Affairs for Medical Devices (M.Sc./P.Grad.Dip)

Overview

Course Overview

In recent years, the medical device regulation in Europe has undergone a fundamental redesign and this is leading to changes in market dynamics and the nature of the medical device ecosystem. 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.

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.

Is This Course For Me?

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.

Career Opportunities

Ireland is a global leader in medical device development, manufacturing and export, and it has the highest per capita employment in the MedTech sector in the EU. Medical devices are an increasingly important component of modern, integrated healthcare.

This programme will help graduates develop a career in a MedTech organisation, as well as enter the public- and private-sector regulatory environment for these devices. Graduates can also undertake further academic research at Trinity and other global universities.

Course Structure

To achieve the Masters programme, students must complete a dissertation, as well as the taught modules (worth 90 ECTS). The distribution of credits is 45 ECTS of taught modules in Year 1 and 45 ECTS in Year 2, including 30 ECTS of research dissertation.

These modules include:

• Introduction To Device Regulation, Regulatory Roles and Responsibilities
• Person Responsible for Regulatory Compliance
• Clinical Development Strategy
• 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

Course Content

The course is a part-time taught program run over two years, with a total of 12 modules and a dissertation. Five modules are delivered online. In-person modules typically include three days of face-to-face teaching (combining formal teaching, workshops, and practical sessions).

Throughout the year participants are required to attend, in person or virtually, tutorials, workshops, lectures, networking events and examinations. These are designed to facilitate students working while undertaking the course. Tutorials accompany a majority of the online or in-person lectures.

Click here for further information on modules/subjects.