This online e-Learning course comprises two modules 1. Principles of Medical Device Design and 2. EU Regulation of Medical Devices and 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 content will be accessible online and participation is self-paced within defined timeframes. Each module will be supported by a 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 CRDI certificate and CRDI open badge will be awarded to all successful course participants including those eligible for ECTS*/**/***.
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
- 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 outline the basis for EU Medical Device Regulatory revision; explain the key changes and their potential for impact on the device development process
Course Accreditation & CRDI Open Badge
The course content will be examined thereafter by online MCQ.
- Please note this course bears 5 ECTS credits for eligible NUI Galway registered students
- PhD researchers who wish to avail of ECTS must, in addition to registration with CRDI, register formally for this course with their own 3rd level institution (NUIG course code MD8000). Registration with CRDI alone will not suffice for 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.
- CRDI certificates of attendance will be provided to those not eligible for, or requiring, ECTS.
- CRDI certificates of completion and CRDI Open Badges (see below) will be awarded to all successful course participants including those eligible for ECTS.
CRDI Open Badge
- A CRDI Certificate of attendance will be awarded to those who do not wish to take the exam (Full attendance in all course sessions is required)
- A CRDI Open Badge will be awarded to those who successfully complete the online MCQ (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).
Further details on this CRDI Open Badge here
Please visit https://crdi.ie/education/courses/ to see next run of the course details (See 'Upcoming Courses' section)