The Higher Diploma Medical Technology Regulatory Affairs Professional will be delivered and accredited through GMIT.
This 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 participants must have at least a level 8 qualification or equivalent work experience prior to acceptance onto this course. It is especially suitable for participants intending to work in regulatory affairs and quality related roles.
The course will:
Provide a wholistic solution for participants to gain practical & theoretical understanding of regulatory affairs activities for the Medical Technology sector.
Support the Medtech industry by ensuring that students are well practiced and educated on the specific regulations and associated application methods for Global markets.
Incorporate practical industry experience that will ensure that students can immediately apply knowledge and competence.
This will include 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 aspects of the business Auditing & Technical Writing competency:
- Regulatory Affairs Business Strategy including Pre-market & Post-market responsibilities.
- Clinical Evaluation masterclass series:
- S. Regulations: How to do a 510k or PMA
- EU Regulations: MDR 2017/745 &/or IVDR 2017/746
- Global Regulations & Medical Device Single Audit Programme (MDSAP):
- Post Market Surveillance activities including Eudamed
- SAMD: Software as a Medical Device.
* Where a student has already completed the Fundamentals in RA programme via Springboard or Skillnet an exemption can be obtained.
Entry requirements for applicants
Participants must have at least a level 8 qualification, or equivalent work experience, prior to acceptance onto this course.
All employed participants will be required to pay 10% of the overall costs of the programme. 10% cost is €690.00 per person.
The following documents must be attached to your application; (Whichever document is relevant to your status)
- If you are employed – a letter from your employer / employment summary (previously a P60) confirming you are employed.
- If you are a homemaker you need to have a letter confirming this, signed by commissioner of oath.
- If you are unemployed you need to send a copy of your job seeker benefit/allowance slip, or a letter from your social welfare office.
- Copy of transcripts to support your academic history.
Note: By applying to this course, through the Irish Medtech Springboard, you are agreeing to your data being shared with the relevant staff and trainers within the Irish Medtech Springboard, and GMIT, to facilitate this level 8 award; Higher Diploma Medical Technology Regulatory Affairs Professional.
To confirm eligibility on Springboard courses, please go to https://springboardcourses.ie/eligibility