Clinical Evaluation - I3CGLOBAL

Clinical Evaluation chapter VI of the new Medical Device Regulation 2017 745 article 61 details general safety and performance requirements to be met by all devices under normal conditions for use for the intended purpose of the device.A detailed assessment of clinical data with sufficient clinical evidence pertaining to side-effects and acceptability of the benefit-risk-ratio to verify clinical safety and performance is called Clinical Evaluation. (refer to MEDDEV Clinical Evaluation Procedure)

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