The Clinical Industry Liaison Officer delivered a number of key training sessions on medical device development in 2016. The focus of these sessions included topics on clinical strategy for medical device development, integrating human factor engineering into design/product development, good clinical practice (GCP) for medical device clinical investigations, ethical considerations in clinical trials/investigation in human’s, types of clinical investigations, clinical investigation planning, clinical investigation conduct and key considerations when developing a medical device that incorporates software.
The key topics were delivered through interactive sessions, case studies, presentations and discussions, resulting in a better understanding on the importance in developing a clear well thought through clinical strategy when developing a medical device.
The training sessions were delivered to the Diploma/MSc in Pharmaceutical Medicine Trinity Centre for Health Sciences St James’s Hospital, Masters and Graduate Certificate in Clinical Research, St Vincent’s Hospital, MSc Medical Technologies Regulatory Affairs, NUIG, BioInnovate, NUIG and Digital Hub as well as targeted GCP training for individual companies initiating clinical investigations in Irish hospital.
Integration of GCP and ethical considerations as well as human factor engineering in the development and life-cycle management of a medical device is a key factor and will reduce the risk of safety issues for end users and patients.
With the changing regulatory landscape and complexity in the development of medical devices, researchers and companies need to improve their knowledge in how they approach their development plans.
2016 Training Sessions
– Clinical Strategy for Medical Devices Development, Diploma/MSc in Pharmaceutical Medicine Trinity Centre for Health Sciences St James’s Hospital, 22nd January 2016 & 23rd February 2016
– Integrating Human Factors Engineering into the Design (product development) Process” Enterprise Ireland, 25th January 2016
– Clinical Strategy for Medical Devices Development, Masters and Graduate Certificate in Clinical Research, St Vincent’s Hospital, 09th March 2016
– GCP Medical Device Training, Neuromod, Nexus, UCD, 08th April 2016
– Ethical Considerations in Clinical Trials/Investigation in Human’s, Athlone Institute of Technology, 20th April 2016
– Series of lectures for MSc medical Technologies Regulatory Affairs, NUIG:
- Introduction to GCP Medical Devices ISO 14155:2011, NUI Galway, 02ndFebruary 2016
- Types of Clinical Investigations and Clinical Investigation Planning, NUI Galway, 10thFebruary 2016
- Clinical Investigation Conduct and Ethical Considerations, NUI Galway, 17thFebruary 2016
- Sponsor and Investigator Responsibilities, NUI Galway, 24thFebruary 2016
– Considerations when Developing a Clinical Investigation, BioInnovate, Galway, 21st April 2016
– Software as Medical Device “Factors to Translate Software in the Healthcare Arena”, Digital Hub, 30 November 2016
Future Training Events
All future medical device development training events will be advertised on the training-conferences section of our website. Please join the HRB CRCI mailing list, to be promptly informed of all upcoming HRB CRCI events. For further information, or to discuss how we can assist you, please contact the Clinical Industry Liaison Office