Higher Diploma in Science in Medical Technology Regulatory Affairs Featured Image

Universities Ireland Atlantic Technological University - Galway Courses Higher Diploma in Science in Medical Technology Regulatory Affairs

Higher Diploma in Science in Medical Technology Regulatory Affairs
at Atlantic Technological University - Galway

Galway, Ireland

Tuition Fee € 12,000
Country Rank#19
Duration12 Months
Score IELTS: 6 TOEFL: 80

Program Overview

The Higher Diploma Medical Technology Regulatory Affairs Professional will be delivered and accredited through Atlantic Technological University (ATU) Galway.

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.

Course Content
Modules:
- Fundamentals in Regulatory Affairs - Introduction
- Quality Management, Regulatory Strategy and Audit Practices
- Design Controls, Risk Management and Clinical Studies for Medical Technology Industry
- Medical Technology Regulations for the U.S. Market
- Medical Technology Regulations for the EU market
Entry Requirement
Applicants will require the following:
- A personal statement
- Evidence of relevant work experience
- Honours Degree (H2.2) in any related degree.
Fees & Scholarships
For International Students: €12,000 per year.
Career Prospect
The knowledge gained in this programme is critical to all technical roles in the Life Science Sector. Research & Development Engineers along with Manufacturing Eng., Quality & Testing Specialists and Regulatory Professionals must understand what Global regulations need to be met & how the framework is applied.

Cost Of Studying At Atlantic Technological University - Galway

Interest rates as low as 8.9% ^*

250K+

Students Assisted

800Cr+

Loan Amount Disbursed

5000+

Loans Sanctioned

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Higher Diploma in Science in Medical Technology Regulatory Affairs at Atlantic Technological University - Galway