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European Clinical Trial Medical Device Regulation and the Protection of Human Participants /
(2018)
The focus of this research is in the area of European clinical trial regulation for medical devices to determine if the health and welfare of human participants is protected. There were four questions to be addressed: 1) ...
Challenges for the Regulatory Affairs Function in Demonstrating Compliance for Existing CE Marked Devices to the New EU Medical Devices Regulation 2017/745 /
(2019)
The Medical Device industry in Europe, and specifically Ireland, is a critically important manufacturing sector underpinned with strong potential for further growth in the coming years. To place any Medical Device on the ...
Investigation into the challenges encountered by regulatory affairs professionals working in the Medtech industry /
(2017)
This research focused on the challenges experienced by Regulatory Affairs professionals working in the Medtech industry. Initial brainstorming with regulatory colleagues who have greater than ten years’ experience identified ...
Multiregional Medical Device Registration /
(2017)
The landscape of multiregional medical device registration is an area with highly variable regulations, varying regulator application and expectations, alongside swift changes in some regions.
Accessing international ...