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Fundamentals in Medical Device Design and Regulation – New e-Learning initiative

The CRDI / CÚRAM Partnership is pleased to announce the recent launch of its new e-Learning course ‘Fundamentals in Medical Device Design and Regulation’, with the first intake of 24 postgraduate and postdoctoral researchers from CÚRAM and partner institutions registering to take part in December 2017.

The course 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 such as biocompatibility, as well as processes involving biomaterials and biomechanics in medical device design.

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 more on the CRDI / CÚRAM Partnership, see: https://www.crdi.ie/research/curam/

For more on CÚRAM, see: http://curamdevices.ie/


For further details on the Fundamentals in Medical Device Design and Regulation course please contact the CRDI / CÚRAM Partnership Project Manager, Dr. Anne-Marie Miller at annemarie.miller@crdi.ie.

The CRDI / CÚRAM Partnership project is funded by Science Foundation Ireland (SFI) and the European Regional Development Fund (Grant Number 13/RC/2073)