CÚRAM Learning - Guidance, Information and Training
A core objective of CÚRAM e-Learning is the development of key information and training tools to support excellence in medical device research in Ireland.
Modules focus on the core principles of medical device design and development and also cover the key regulatory requirements for placing a medical device on the EU market. These modules are integrated into the centre’s education and training programme by the CÚRAM Education and Training Steering Committee comprising representation from medical device researchers from academia and industry, clinician scientists, teaching and learning leads, and clinical trials methodology experts.
This material complements existing professionalism and career development opportunities, which include the Research Integrity and Future Innovators Training programmes.
Current e-Learning courses offered include:
Fundamentals of Medical Device Design and Regulation (Module # MD8000)
Expressions of interest are now closed
This course, accredited for 5 ECTS in NUIG, is designed to impart important industry, research and regulatory concepts relevant to the entire life cycle of medical device development. It comprises two modules:
a) Principles of Medical Device Design - integrates the approaches of engineering and life sciences.
This module introduces the learner to the fundamentals of medical device design, delivering key concepts such as biocompatibility and processes involving biomaterials and biomechanics. It also discusses the multi- and inter-disciplinary nature of the field and describes the medical device industry in Ireland
b) EU Regulation of Medical Devices - provides an introduction to the EU regulatory framework.
This module introduces the EU Medical Devices Regulatory Framework, describes CE marking and conformance assessment processes, their requirements and the obligations placed on the manufacturer in this regard. This knowledge is designed to support device design and development, and facilitate further study or training in the area of EU medical device regulation
Expressions of interest are now closed
Quality and Standards for Medical Devices - coming soon – 2021!
We are excited to announce that our new online module ‘Quality and Standards for Medical Devices’ will launch in early 2021.
For further information contact educationcuramdevices@nuigalway.ie
The QSMD module introduces course participants to the quality management and quality management system requirements for medical device development. It also describes the role played by International Standards and EU legislation in shaping the integration of these requirements into business as well as device design and development practices. In particular this course emphasises the ‘whole life cycle’ nature of QMS and how QMS integrates into business systems such as risk management, clinical evaluation and post-market obligations. Accordingly, the roles and responsibilities of the key stakeholders in medical device design and development including Manufacturers, Competent Authorities and Notified Bodies are discussed as well as the fundamental linkages between QMS and the CE marking market approval process. Consequently, ISO 13485: 2016, QMS as a process based model, quality system core processes, auditing, and EU regulatory requirements are covered in greater detail.
Acknowledgements
CRDI CÚRAM Partnership
These e-Learning modules, in supporting the progression of device research and development, are an important output of the Clinical Research Development Ireland (CRDI) / CÚRAM collaborative partnership.
The partnership focuses on the development of methods and media to support excellence in medical device research to include raising awareness of the potential of regulation to impact the successful translation of medical device research. Work focuses on capturing clinical medical device development experience and the provision of training and information resources with a view to promoting the incorporation of ‘principles of best practice’ from the earliest stages of research right through all stages of the device development process.
Stakeholder engagement
The core objectives of the partnership as well as the development and delivery of its initiatives were underpinned by the support and advice of industry, regulatory and clinical trials experts. The partnership would, in particular, like to acknowledge the significant contribution made by the National Standards Authority of Ireland, the Health Products Regulatory Authority, Aerogen Ltd and HRB Clinical Research Coordination Ireland to the realisation of partnership ambitions.
Financial support
Partnership outputs have emanated from research conducted with the financial support of Science Foundation Ireland (SFI) and the European Regional Development Fund (ERDF) under grant number 13/RC/2073.