Higher Diploma in Science in Medical Technology Regulatory Affairs

The 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.

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

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.  There is no other programme that equips participants with this up to date knowledge and having this qualification on your cv will reduce the burden on industry to train you on-site.

Name: Carmel McGrath,

Course Director & Adjunct Lecturer ATU

carmel@associate.gmit.ie

Tel: 087-4185458