Higher Diploma in Science in Medical Technology Regulatory Affairs
The Higher Diploma Medical Technology Regulatory Affairs Professional will be delivered and accredited through Atlantic Technological University (ATU) Galway.
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.
This course will provide a practical solution for participants to gain practical & theoretical understanding of regulatory affairs activities for the Medical Technology sector.
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.
As an introduction the current Fundamentals in Regulatory affairs will be provided, this is a pre-requisite and will provide participants with the basic understanding required to proceed to advanced regulatory modules. Also, those who have already completed this course can obtain an exemption.
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.
Carefully selected course tutors will bring a blend of Industry, Regulatory Authority and Academic expertise with current teaching methods and on-line systems applied.
- *Fundamentals in Regulatory Affairs
- Quality Management, Regulatory Strategy & Audit Practices
- Design Controls, Risk Management & Clinical Studies for Medical Technology Industry
- Medical Technology Regulations for the U.S. Market
- Medical Technology Regulations for the EU Market
- Major Global Markets
- Medical Device Safety Monitoring and Incident Reporting
* Where a student has already completed the Fundamentals in RA programme via Springboard or Skillnet an exemption can be obtained.
(We would like to highlight the need for students to have headsets/mics/camera and good Internet access for the course. A good internet connection will be essential for students to get the most out of the course and end of semester online assessments)
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Why Study this course?
Make a difference in the life of patients by contributing to advancing medical technology.
Significant promotional and career advancement opportunities
Stepping stone to further education i.e. Masters in Medical Technology or Msc in Regulatory Affairs.