Higher Diploma in Science in Medical Technology Regulatory Affairs

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 & IVDs. Within one academic year, you will be considered a major asset to the regulatory profession and immediately integrate into the business.