HIGHLIGHTS
SUMMARY
In all, 3 dimensions must be considered: technical aspects, regulatory framework, and usability of the device. To be adopted, the medical device must be usable, useful, satisfying, and safe for future users. Full compliance with the European regulations relating to medical devices (European Union Medical Device Regulation 2017/745) is required for the device to enter the market. Adoption-when all potential users are involved from the early design phases, clinical adoption of the device is generally much high. This medical device will be developed according to feedback from technical tests and the next . . .
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