CRDI/CÚRAM Partnership Project
Clinical Research Development Ireland, is a funded partner in CÚRAM. The CRDI / CÚRAM Partnership Project entitled ‘Developing Key Structures and Resources to Support Medical Device Clinical Research in Ireland’ provides significant opportunities to advance medical device clinical research through the development of education, training and information resources designed to impart important industry, research and regulatory concepts relevant to the entire life cycle of medical device development.
Project deliverables include an interactive e-Learning module and web-portal designed to support the acquisition of skills and knowledge on medical device regulation, map regulatory requirements and pathways to the medical device life cycle, signpost users to regulatory organisations and provide access to pertinent resources and documentation as well as supporting cross-sector connections (academic/clinical/industry) to support medical device innovation.
Significantly, the ongoing success of this work is underpinned by constructive engagement with industry, regulators, academic researchers, clinicians and the national clinical research infrastructure.
CRDI /CÚRAM Partnership Project Management
CRDI Project Manager, Dr. Anne-Marie Miller [Hyperlink CÚRAM profile], is responsible for, conducting the regulatory analysis work and project management of related development activities. She reports to Lead Investigator and CRDI Head of Programmes, Dr. Mark Watson. The work is carried out in close collaboration with Prof. Matthew Griffin (Professor of Transplant Biology, NUI Galway), Prof. Martin O’Donnell (Professor of Translational Medicine at NUI Galway ) and Prof. Abhay Pandit (Scientific Director, CÚRAM), and is part of the CURAM Translation Support platform.
As part of this work we reviewed the recent changes in the medical device legislation in the publication ‘New EU medical device regulations: Impact on the MedTech sector’ (Medical Writing (Medical Devices). 2017; 26 (2): 20-24)