Atlantic Technological University (ATU) is a college that places teaching and research at its core. ATU aims to provide students with a transformative university experience that prepares them to make significant contributions to society. With a focus on applied learning, teaching, and research that reflects the needs of businesses and professions in the region, ATU strives to be a preferred partner for research and innovation. The university seeks to attract and support students and staff from around the globe, enabling them to reach their full potential.

Show less

This programme is funded through the Irish Medtech Springboard. It is a 60 credit NFQ Level 8 award based on the need to provide an ongoing skilled workforce to the Medical Device sector. Especially with the introduction of the new European Medical Device Regulation (MDR) coming into effect in May 2021 and the In Vitro Diagnostic Device Regulation (IVDR) implementation due in 2022, this course is designed to ensure participants will be educated in these new requirements while also understanding the Global regulatory framework. Programme Supports Medtech industry by ensuring that students are well informed and educated in-depth on the specific regulations and associated safety & performance application for medical devices & IVD’s. Within one academic year, you will be considered a major asset to the regulatory profession and immediately integrate into the business. This programme includes a blended learning approach with 10 contact hours on a weekly basis over 3 semesters resulting in 60 ECTS. Continued assessment methodology will be applied with course advancement linked to achieved interaction & results. The ultimate aim of the programme is intended to provide a qualification for graduates (employed/unemployed) to undertake or progress in a Medical Technology Regulatory affairs career. The need for the programme was inspired by a specific demand from industry to meet the clear need to upskill/hire personnel for the regulatory affairs function. In addition, participants who want to aspire to management level within the Regulatory Affairs profession can further develop their skills and offer immediate value to the business on programme completion. Show less

Course Details
Over two Semesters participants will be tutored by industry and regulatory body experts on the major global regulations and appropriate application framework. They will be equipped to better support their company in achieving market approval & post approval maintenance through the practical learning this course provides. The following modules will be delivered, 3 in Semester 1 & 4 in Semester 2 with ongoing assessment applied. There is no final exam. Participants must pass each module

Modules:
1. Fundamentals in Regulatory Affairs
2. Quality Management, Regulatory Strategy & Audit Practices
3. Design Controls, Risk Management & Clinical Studies for Medical Technology Industry
4. Medical Technology Regulations for the U.S. Market
5. Medical Technology Regulations for the EU Market
6. Major Global Markets
7. Medical Device Safety Monitoring and Incident Reporting

Apply Now
Share
Print

Year 1
Fundamentals in Regulatory Affairs - Introduction
10 credits

Quality Management, Regulatory Strategy and Audit Practices
5 credits

Design Controls, Risk Management and Clinical Studies for Medical Technology Industry
10 credits

Medical Technology Regulations for the U.S. Market
10 credits

Medical Technology Regulations for the EU market
10 credits

Major Global Markets
5 credits

Medical Device Safety Monitoring and Incident Reporting
10 credits

Show less