Expressions of interest are invited for the Online CRDI Course Fundamentals in Medical Device Design and Regulation.
Fundamentals in Medical Device Design and Regulation 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.