ONLINE CRDI Course: Fundamentals in Medical Device Design and Regulation

Course Description


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 Information


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

  • Content Online: 12th November 2018
  • Workshop: 18th Jan 2019
  • Venue: Biomedical Sciences Building, NUIG
  • Online Examination: : 4 – 5pm, 23rd Jan 2019

Module 2 - EU Regulation of Medical Devices

  • Content Online: : 28th January 2019
  • Workshop: TBC March 2019
  • Venue: Biomedical Sciences Building, NUIG
  • Examination: TBC March 2019

 

Registration


Registration for expressions of interest is closed

*Full participation in all course components is required for attainment of ECTS, award of CRDI certificate and/or open badge as appropriate

** Course workshops will be delivered in CÚRAM, Biomedical Science Building, NUIG unless otherwise stated

*** PhD researchers who wish to avail of ECTS academic year 2018 / 2019 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. 


Course Content


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

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 outline the basis for EU Medical Device Regulatory revision; explain the key changes and their potential for impact on the device development process

Registration


Registration for expressions of interest is closed

*** PhD researchers who wish to avail of ECTS academic year 2018 / 2019 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.