Fundamentals of Medical Device Design and Regulation (Module # MD8000)
CÚRAM is pleased to announce that it’s successful e-Learning course ‘Fundamentals in Medical Device Design and Regulation’, developed in collaboration with Clinical Research Development Ireland, will again be available to CÚRAM, and partner institution, PhD students, Post-Doctoral researchers and staff this academic year 2020 / 2021.
The course, which bears 5 ECTS, is designed to be highly interactive. It supports the acquisition of state of the art biomedical, regulatory and clinical research knowledge with much of its content produced in collaboration with national and international experts. The course benefits from the input of national agencies including the Health Products Regulatory Authority and the National Standards Authority of Ireland as well as the involvement of key industry partners including pharmaceutical and medical device companies.
Fundamentals in Medical Device Design and Regulation comprises two modules, Principles of Medical Device Design and EU Regulation of Medical Devices. It has been developed to impart important industry, research and regulatory concepts relevant to the entire life cycle of medical device development.
The course is designed so that on completion participants appreciate the multi- and inter-disciplinary nature of the field, have good insight of the medical device industry in Ireland, and understand key concepts central to the device development process such as biocompatibility and systems involving biomaterials and biomechanics.
In addition, participants learn about the existing legislative framework for medical device regulation in the EU and how this applies to medical device research and development. Recent revisions to the EU medical device regulatory framework are covered along with a brief review as to how the key changes will affect medical device research and development going forward.
For further details or to register an expression of interest please use the form below:
Course Description
This online e-Learning course comprises two modules 1. Principles of Medical Device Design and 2. EU Regulation of Medical Devices. It has been developed to impart important industry, research and regulatory concepts relevant to the entire life cycle of medical device development. On successful completion of this course participants will appreciate the multi- and inter-disciplinary nature of the field and have good insight of the medical device industry in Ireland, they will also understand key concepts such as biocompatibility as well as processes involving biomaterials and biomechanics in medical device design. In addition, participants will also learn about the existing legislative framework for medical device regulation in the EU and how this applies to medical device research and development. Recent revisions to the EU medical device regulatory framework are also covered along with a brief review as to how the key changes will affect medical device research and development going forward [see videos below].
Course participation is self-paced within defined timeframes. Each module will be supported by a (compulsory) 2 hour workshop which will be delivered at the end of the online period. The course content will be examined thereafter by online MCQ. This course bears 5 ECTS for eligible post-graduate researchers. A CÚRAM certificate and CÚRAM open badge will be awarded to all successful course participants including those eligible for ECTS.
Course Content
MODULE 1: Principles of Medical Device Design
- Session 1: Introduction to Medical Devices
- Session 2: Medical Device Industry in Ireland
- Session 3: A Biomaterials Design Perspective
- Session 4: Design of an Orthopaedic Implant
- Session 5: Concepts of Biocompatibility
- Session 6: Regenerative Medicine
- Session 7: Neural Device Interface
- Session 8: Design by Self Assembly
- Session 9: Therapeutic Angiogenesis
- Section 10: Tissue Engineering
MODULE 2: EU Regulation of Medical Devices
- Session 1: Medical Device and Regulatory Fundamentals
Key stakeholders, Legal instruments, Definitions - Session 2: Medical Device Technical, Health and Safety specifications
Medical Device Directives/Regulations and CE Marking - Session 3: Risk Classification, Conformity Assessment and CE Marking
Essential requirements and Harmonised Standards - Session 4: Clinical Evaluation and Clinical Investigation
Clinical Evaluation and Clinical Investigation processes - Session 5: Post-Market Activities
Post-Market Surveillance and Post-Market Vigilance - Session 6: Basis for EU Medical Device Regulatory Framework Reform
Drivers of change and key outcomes
Indicative Learning Outcomes
On successful completion course participants should:
1. understand the multi- and inter-disciplinary nature of medical device development
2. have insight of the medical device industry in Ireland
3. understand:
- the concepts of biocompatibility
- the processes involved in the use of biomaterials
- the principles of biomechanics
- the principles of medical device design
4. understand the legislative framework for medical device regulation in the EU
5. be able to explain the purpose of, and processes involved in CE marking and conformity assessment
6. define and explain the importance of clinical data, clinical evaluation and investigation
7. understand post-market regulatory requirements: surveillance and vigilance
8. be capable of outlining the basis for EU Medical Device Regulatory revision; explain the key changes to the regulatory framework and their potential for impact on the device development process
Important! - Course Accreditation & CÚRAM Open Badge
ECTS Credits
- Please note this course bears 5 ECTS credits for eligible PhD registered students.
- PhD researchers who wish to avail of ECTS must, in addition to submitting an expression of interest here, register formally for this course with their own 3rd level institution (NUIG course code MD8000). Submission of an expression of interest via this portal alone will not sufficefor award of ECTS.
- Students not registered with NUI Galway may be eligible for award of ECTS through NUI Galway. Please check with your own college graduate office regarding your eligibility for ECTS.
- CÚRAM certificates of completion and CÚRAM Open Badges will be awarded to all successful course participants including those eligible for ECTS.
CÚRAM Open Badge
- A CÚRAM Certificate of attendancewill be awarded to those who do not wish to take the exam (full attendance in all course sessions and both workshops is required).
- A CÚRAM Open Badgewill be awarded to those who successfully complete the online MCQ examination (Date tbc). This Open Badge is provided as a measure of CPD attainment.
What is an Open Badge?
Open Badges are verifiable, portable digital badges with embedded metadata about skills and achievements. They comply with the Open Badges Specification and are shareable across the web (Social Media, e-Portfolio, Blogs or Online CVs).