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Fig. 2 | Artery Research

Fig. 2

From: Medical Device Regulation: Should We Care About It?

Fig. 2

Within the Biodesign framework describing the innovation process for medical technologies [8], unmet clinical needs have to be identified, solutions to address them have to be invented and systems for the end-users have to be implemented. Different stake-holders are involved and each phase has to deal with Regulation

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