Medical Technology Regulatory Affairs & Quality - Sligo
The course will enable Regulatory Affairs and Quality personnel in the Medical Technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of regulatory affairs and quality.
Introduction to Quality Management Systems
Fundamentals of EU Medical Device Regulations
Auditing and Compliance
Fundamentals of US Medical Device Regulations
Risk Management and Design Control
Validation and Calibration
Fundamentals of Global Medical Device Regulations
Sterilisation and Biocompatibility
Operations Management and GMP
Fundamentals of Medical Device Clinical Trials
Introduction to Market Vigilance and Labelling
Technical Report Writing
Level 7 qualification in a relevant area of Science, Engineering or Technology.
Applications for online programmes are accepted on the atu sligo website.
All programmes advertised will run subject to sufficient student numbers.
ATU sligo online has two intakes per year, the main one being in September with a smaller listing of programmes for January. For confirmation on start dates check www.itsligo.ie/online
For September, applications open from 1st February each year. Closing date for receipt of applications is 31st august.
For January, applications open from 1st November each year. Closing date for applications is mid-January.
The online application form requires personal details, previous qualifications, professional accreditations, employment history and a personal statement. We recommend collating all the necessary paperwork i.e. Transcripts of previous qualifications, academic certificates before you submit an application.
Once submitted, our admissions team will contact you to confirm eligibility and request copies of any previous qualifications.
Academic staff review every application and approve eligible candidates for the programme.
Admissions team will notify you if you are accepted onto the course and will request deposit to confirm your place.
Places are limited, so please apply early.
Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions.
2 years part-time, online.
One optional workshop each year which is an opportunity to meet lecturers and network with other students.
€4,500 per annum
or €9,000 total.
€900 per module.
Non-EU total fees: €12,000
Next Level Skillnet Member - €1,417.50 per semester*
Fee Next Level Skillnet Non-Member Fee - €2,025 per semester**
* Subject to confirmation of funding support for each semester. See next level skillnet qualifying criteria at http://nextlevel.ie/at-a-glance/employee/
** Companies who do not qualify under the Next Level Skillnet criteria may still enrol on the course at the Non-Member rate by contacting Next Level Skillnet, firstname.lastname@example.org
Contact the college for the next start date.
Post Course Info
This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs or Quality environment within the highly successful and growing Irish Medical Technology industry sector.
The Level 8 Higher Diploma and Certificate in Medical Technology Regulatory Affairs and Quality programme has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a taskforce comprised of regulatory experts from industry, industry practitioners and representatives from the regional skills for a west and north west.
The Irish Medical Devices Association (IMDA) states "The medical technology sector in Ireland is recognised as one of the five global emerging hubs. The sector employs over 29,000 people in Ireland and is the second largest employer of medtech professionals in Europe. Ireland is one of the largest exported of medical products in Europe with annual exports of €12.6 billion and companies here directly export to over 100 countries worldwide. As many as 18 of the world's top 25 medical technology companies have a base in Ireland and 50% of the 450 medtech companies based here are indigenous."
The sector is, by its nature, highly regulated; all disciplines involved in the design, manufacture and distribution of a medical device are controlled by medical device regulations. Given the unique need for regulatory affairs knowledge and understanding at all stages of a medical device product lifecycle there is a strong need for the medical technology industry to have available to it appropriate courses to satisfy this information and skills need. The Forfás National Skills Bulletin 2016 further supports this need as it identified a skills shortage for regulatory professionals and quality control engineers.
Graduates with the Higher Diploma award will be eligible to apply to undertake the MSc. in Medical Technologies Regulatory Affairs, a part-time distance learning Level 9 programme jointly delivered by NUI Galway and ATU Sligo.