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Medical Device Risk Evaluation and Risk-Benefit - ISO 14971

Medical Device Risk Evaluation and Risk-Benefit - ISO 14971

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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.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

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Medical Device Risk Evaluation and Risk-Benefit - ISO 14971