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.

Modules Overview:

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

* 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)

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.

Entry Requirements

Course participants must have at least a level 8 qualification 240 credits (4 year hons degree) prior to acceptance onto this course. It is especially suitable for participants intending to work in regulatory affairs and quality related roles. .

Places will be given to those who are most eligible for the programme.

Eligibility criteria

To confirm eligibility on Springboard courses, please go to https://springboardcourses.ie/eligibility

The following documents must be attached to your application; (Application cannot be processed without these documents attached, once all documents are received online, with your application, status will be updated to pending. Places will be given to those who meet the eligibility criteria and are most eligible for the programme)
1. If you are employed – a letter from your employer / most recent payslip – MUST BE DATED within 6 weeks of the start date of the course.
1. If you are a homemaker you need to have a letter confirming this, signed by commissioner of oath. – MUST BE DATED within 6 weeks of the start date of the course
1. If you are unemployed you need to send a copy of your jobseeker benefit/allowance slip, or letter from social welfare office. – MUST BE DATED within 2 weeks of the start date of the course
2. Copy of transcripts to support your academic history – Proof of Level 8 – 240 credits (4 year degree)
3. CV
4. Proof of Address – Utility Bill/P60 etc.
5. Proof of identification – Passport/Drivers Licience
6. Visa Requirements/Stamp 4 etc.
7. Proof of PPS number

8. Proof of residence – dates must show 3 years residence prior to start of course. Proof for each year 2019, 2020, 2021., or 2020, 2021, 2022, etc.

Irish Medtech Springboard will contact you closer to start date of course (within 4 weeks of start to collect this data prior to enrolment of course)

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 ATU, to facilitate this level 8 award; Higher Diploma Medical Technology Regulatory Affairs Professional.

Fees

All employed participants will be required to pay 10% of the overall costs of the programme. 10% cost is €690.00 per person.

Apply

Click on the link below to apply: 

HEA - Springboard+ (springboardcourses.ie)

If you have any queries please email: 

Name: Michelle Quain

Irish Medtech Springboard course co-ordinator

Michelle.quain@ibec.ie

087-1906802

Name: Carmel McGrath,

Course Director & Adjunct Lecturer ATU

carmel@associate.atu.ie

Tel: 087-4185458