Medical Device Risk Evaluation and Risk-Benefit - ISO 14971

Risk Evaluation and Risk-Benefit Template - EN ISO 14971:2019+A11:2021

The Risk Evaluation and Risk-benefit document is a requirement of the medical device risk management standard EN ISO 14971. Meeting the requirements of this standard helps to fulfil parts of the General Safety and Performance Requirements (GSPR) of both the Medical Device Regulation (MDR) EU 2017/745 and In Vitro Diagnostic Device Regulation (IVDR) EU 2017/746. This template should form part of the Medical Device File (MDF) mentioned in EN ISO 13485:2016.

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