The Higher Diploma in Medical Technology for Regulatory Affairs Professional will be delivered and accredited through Atlantic Technological University (ATU) Galway starts Tuesday 3 October 2023. (Applications close Sunday 24 September)
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 European Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Device Regulation (IVDR) 2017/745 and associated transition timeline changes, 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 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.
The course will provide the following:
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.
As an introduction the current approach and regulatory strategy captured in the Fundamentals in Regulatory affairs module will be provided, this is a pre-requisite and will provide participants with the basic understanding required to proceed to advanced regulatory modules.
The aim of the programme is primarily intended to provide a qualification for graduates (employed/unemployed) to undertake or progress in a Medical Technology Regulatory affairs career. Although, we also have great interest from other functional medical technology professionals who wishes to expand their knowledge of the regulations.
The need for the programme was inspired by a specific demand from industry to meet the clear requirement 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.
The course will be accredited by Atlantic Technological University (ATU) Galway, to Level 8 with 60 credits.
Modules Overview:
- Fundamentals in Regulatory Affairs *
- Quality Management System aspects of the business Auditing & Technical Writing competency
- Regulatory Affairs Business Strategy including Regulatory Intelligence, Pre-market & Post-market responsibilities.
- Clinical Evaluation masterclass series
- U.S. Regulations: How to do a 510k,PMA or DeNova
- EU Regulations: MDR 2017/745 & IVDR 2017/746
- Global Regulations & Medical Device Single Audit Programme (MDSAP)
- Post Market Surveillance activities including Eudamed & Patient Safety requirements.
- SAMD: Software as a Medical Device & future expectations.
* Where a student has already completed the Fundamentals in RA programme via Springboard or Skillnet an exemption can be obtained.
Delivery:
One year program; starts September per ATU academic calendar. Course timetable provided at start of each Semester.
The course is delivered over two semesters by blended learning methods with 10 contact hours on a weekly basis. Semester 1, Sept to Dec, S2 Jan. to May (incl.)
The programme will give all participants very clear and unambiguous information on current regulations. Course slides, reading material and lecture recordings are all provided.
Carefully selected course tutors, all subject matter experts, will bring a blend of Industry, Regulatory Authority and Academic expertise with current teaching methods and on-line systems applied. Course Director for delivery oversight, assignment management and student support ensures satisfactory delivery of the programme.
Integrated Learning:
• Primary delivery two online lectures per week on Tuesday & Thursday evenings Commitment of 10 hours per week is expected!
• Access to ATU Galway Microsoft package.
• Delivery via Moodle platform provided.
• On-line assignments at frequent intervals throughout the modules with Instant feedback on course progress.
Continuous Assessment:
• Practical test of understanding of each module is carried out through ongoing assessment, team projects and class presentations.
• Module Advancement through attainment of required grade is mandatory.
• Formal graduation with Special Diploma Award in-line with the National Quality Assurance (NQA) standards per ATU ceremony schedule.
(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)
Entry requirements for applicants:
Participants must have at least a level 8 qualification of 240 credits (4 year degree) prior to acceptance onto this course.
Applicants whose first language is not English are required to provide evidence of English language proficiency.
All employed participants will be required to pay 10% of the overall costs of the programme to the Irish Medtech Springboard.
10% cost is €690.00 per person.
Fully funded (N/C) if you are unemployed and registered as such with your social welfare office.
If you are successful in your application, Once you accept your place on the course online through springboardcourses.ie website; The following documents must then be attached to your application; (You will not be enrolled for funding unless all relevant data has been received (attached online). Once all documents are received online, with your application, status will be updated to enrolled.
Documents must be in date within six (6) weeks of commencement date of course (not the application date)
1. If you are employed – a letter from your employer / most recent payslip (please redact sensitive data) – MUST BE DATED within six (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 six (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 two (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 Licence
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 2020, 2021, 2022., or 2021, 2022, 2023, 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 Ibec, and ATU Galway, to facilitate this level 8 award; Higher Diploma Medical Technology Regulatory Affairs Professional.
Eligibility criteria
To confirm eligibility on Springboard courses, please go to https://springboardcourses.ie/eligibility
