- Overview
- Course outline
- Entry
- Career path
- How to apply
Course Overview
The Certificate in Medical Device Technology and Regulation provides a comprehensive introduction to the medical device industry, covering device types, classification and lifecycle development. You will explore key areas such as medical device design, biocompatibility, risk management, regulatory requirements, quality systems and clinical evaluation, while developing an understanding of the standards and practices that support safety and compliance across the industry.
You will also gain insights into medical device measurement, data analysis and emerging technologies, including connected devices, digital health and AI applications in MedTech. With industry-informed teaching, practical demonstrations and a flexible part-time blended learning format, the course is designed to help you build relevant knowledge while balancing your studies with work. It also provides an opportunity to progress to the related Postgraduate Diploma or MSc.
ACCREDITATION: QQI Level 9 Special Purpose Award Certificate in Medical Device Technology and Regulation (30 ECTS)
DURATION AND HOURS: This part-time programme runs over two semesters, combining live online classes, directed online activities and face-to-face sessions at Griffith College (Dublin and Limerick locations).
WHO IS THE PROGRAMME FOR:
Designed for graduates and professionals in science, computing, quality, manufacturing, engineering, medicine or related disciplines who want to enter or advance within the medical device industry. The programme suits those seeking focused technical, quality and regulatory knowledge for MedTech while balancing study with work and other commitments.
PROGRESSION
Graduates will also be able to continue seamlessly to the Postgraduate Diploma in Science or MSc in Medical Device Technology and Business at Griffith College.
COURSE CONTENT
Module 1: Medical Device Technology
Medical device types and classification, connected health and mobile devices, human anatomy & Physiology, medical device design cycle, value engineering of medical devices, manufacturing, assembly, packaging & testing, and combination products.
Module 2: Medical Device Quality Systems & Regulation
Medical device regulations – ISO 13485, FDA requirements – Class I, II and III devices, statutory frameworks, medical device design, manufacturing, quality management system elements, validation and change control, facility plant design, and product process validation.
Module 3: Medical Measurement and Analysis
Medical data measurements and analysis, distributed databases, data collection systems & data architectures, data analysis software, data storage and data integrity, data management in product and process design of medical devices.
Entry Requirements
Applicants should hold:
A minimum of Level 8 honours degree (2.2 or higher) in a relevant science, computing, quality, manufacturing, engineering or medical discipline,
or
Equivalent qualifications and/or relevant professional experience through Recognition of Prior Learning (RPL).
Career Opportunities
Potential career opportunities following the successful completion of this course include:
- Design Assurance Engineer
- Product Programme Manager
- Regulatory Affairs Specialist
- Compliance Specialist
- Quality Control Analyst
- Manufacturing Engineer
- Quality Assurance Specialist
- Validation Engineer
DISCOVER FULL PROGRAMMES
Apply Now
Our admissions team are on hand to assist you with your application and answer any questions you may have on the course.
Students who wish to apply to this course should follow the following application process.
Step 1: Enquire through the form at the top right of this page
Step 2: A member of our team will be in contact through phone or email
Step 3: If you are deemed to be eligible for the course, you will be sent an application form by email. You MUST fill in this application form and attach all necessary *documents (CV, ID, Transcripts, etc.)
Step 4: On submission of the completed application form and all documentation, your application will be sent to the associated department for final approval. You will receive an e-mail confirming your place on the programme. (Note: This process can take up to one week particularly during busy admission periods.)
*We accept scanned documents in a pdf format. Pictures of documents are not accepted.
**For those who are applying for Springboard funding, you will be directed to fill out an additional application form on the Springboard website, this is to confirm your eligibility to receive funding
Please note at any time if you have any questions please do not hesitate to contact us by email on admissions@innopharmalabs.com or call us (01) 485 334
Why up-skill for the STEM process manufacturing sectors in Ireland?
- Over 130,000 employed within these industries
- Over 40,000 new jobs predicted
- Over €62 billion in exports
- 9 of top 10 world’s biopharma companies in Ireland
- 8 of the top 10 worlds medtech companies in Ireland
- Over 8,000 new jobs predicted
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