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Ph. D. Online

Medical Technology Regulatory Affairs and Quality

Institute of Technology Sligo

24 months
Duration
6000 EUR/year
2250 EUR/year
Unknown
Tuition fee
Unknown
Apply date
Unknown
Start date

About

This Medical Technology Regulatory Affairs and Quality programme from Institute of Technology Sligo has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles. 

Overview

The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by NUI Galway and IT Sligo in conjunction with selected external professionals and industry practitioners who have all the required expertise, knowledge, skills and experience to deliver the education and training required to the highest international standards.

The Medical Technology Regulatory Affairs and Quality programme from Institute of Technology Sligo 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. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 60 credits.

Programme objectives are:

  • Provide participants with a fundamental grounding in medical device regulatory structures and requirements.
  • Provide the training necessary to convert personnel employed in the Medical Technologies sector with life sciences qualifications (Level 6, Level 7, or Level 8) to transition into specialist roles in the medical technology quality assurance and/or regulatory affairs functions and to upskill medical technology professionals in the regulatory framework in their existing roles.
  • Foster the participant’s intellectual development in academic and industrial environments.
  • Develop participant's skills to work and communicate with appropriate autonomy and effectively through various media.

Career Opportunities

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.

Programme Structure

Courses include:

  • 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

Key information

Duration

  • Part-time
    • 24 months

Start dates & application deadlines

Language

English
IELTS admission requirements IELTS The International English Language Test System (IELTS) tests your English-language proficiency on a scale of 1 – 9. The score refers to the combined average score of 4 subjects (writing, listening, speaking, and reading).
6
Start practicing IELTS today!
TOEFL admission requirements TOEFL® IBT The TOEFL iBT® is given online through the internet at designated testing site. The test measures your English-language abilities in an academic setting. The score refers to the total score of 4 subjects (writing, listening, speaking, and reading), each subject has a range of 0 - 30.
80

Credits

60 ECTS

Delivered

Online

Academic requirements

We are not aware of any academic requirements for this programme.

English requirements

IELTS admission requirements IELTS The International English Language Test System (IELTS) tests your English-language proficiency on a scale of 1 – 9. The score refers to the combined average score of 4 subjects (writing, listening, speaking, and reading).
6
Start practicing IELTS today!
TOEFL admission requirements TOEFL® IBT The TOEFL iBT® is given online through the internet at designated testing site. The test measures your English-language abilities in an academic setting. The score refers to the total score of 4 subjects (writing, listening, speaking, and reading), each subject has a range of 0 - 30.
80

Other requirements

General requirements

  • Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme. 
  • Applications from candidates who hold a Level 7 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and /or regulatory affairs will be considered. Candidate interviews may be used to assess candidates’ suitability for the programme.

Tuition Fee

To alway see correct tuition fees
  • International

    6000 EUR/year
    Tuition Fee
    Based on the tuition of 12000 EUR for the full programme during 24 months.
  • EU/EEA

    2250 EUR/year
    Tuition Fee
    Based on the tuition of 4500 EUR for the full programme during 24 months.

Funding

Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.

Fresh content

Updated in the last 6 months

Check the official programme website for potential updates.

Our partners

Medical Technology Regulatory Affairs and Quality
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Institute of Technology Sligo

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