Author:
Abela E.,Farrugia P.,Gauci M. V.,Vella P.,Cassar G.,Balzan E.
Abstract
AbstractNumerous and complex sequence of activities in medical device development often result in time consuming and expensive engineering processes. In this study, patient and designer requirements were identified and integrated within a novel framework which supports medical device design through a consolidated understanding of user-experience whilst directly coalescing the applicable regulatory requirements in terms of product compliance and certification. This assists in the development of safe and reliable products which reflect the need for increased usability considerations during design.
Publisher
Cambridge University Press (CUP)
Reference21 articles.
1. Impact of regulations on innovation in the field of medical devices;Guerra Bretaña;Research on Biomedical Engineering,2018
2. Redesign and Ergonomic Analysis of Scoop Stretcher for Full Body Immobilization during Casualties;Mohammed;Research into Design Across Boundaries,2015
3. Medical device error and failure reporting: Learning from the car industry;Tase;Journal of Patient Safety and Risk Management,2021
4. ISO (2019), ISO 14971:2019: Application of risk management to medical devices, ISO, Geneva
5. Usability and user experience of medical devices: An overview of the current state, analysis methodologies, and future challenges;Bitkina;International Journal of Industrial Ergonomics,2020
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