Risk Management Guidance

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Risk management requirements and standards have become more stringent and difficult to meet ever since MDR and IVDR entered into force.

This tool does not only provide guidance on how to assess the risk of medical devices in the best way possible in line with the new Regulations and updated ISO 14791:2019, but also provides you with a template development section in accordance with ISO 14791:2012. The document delivered to you is in a pdf modifiable format.

PREVIEW Risk Management Guidance Categories: IVDR, MDR