Journal
HEART LUNG AND CIRCULATION
Volume 30, Issue 11, Pages 1658-1666Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.hlc.2021.06.517
Keywords
Vascular ageing; Medical device; Regulation; Innovation
Categories
Funding
- COST (European Cooperation in Science and Technology) [CA18216]
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The development and use of medical devices are subject to regulations and approval activities, impacting manufacturers and professionals involved. Collaboration among various industries and partners can accelerate innovation processes, increase system efficiency, and enhance social and ethical impact.
The development and use of medical devices are subject to regulations and approval activities to enter the market. These are mandatory for manufacturers and have important implications for all involved professionals. In fact, the innovation process, starting from a clinical need, includes the identification of a solution and its implementation, and requires taking into account crucial aspects according to regulatory requirements in each phase. These include exemplary validation or risk management. The aim of this work is to provide an overview of some key aspects of regulation and their implementation in medical devices for vascular ageing assessment. In particular, regulatory scenarios in Europe, Australia and the United States of America are described and examples of marketed medical devices for vascular ageing assessment are provided. Strong and active links among industry, research, clinical experts and governments adds value for the community, requiring the ability to communicate between different skills and backgrounds: this multidisciplinary and multi-partner collaboration can speed up the innovation process and can increase the system's efficiency related to both social and ethical impact.
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