Risk Management Plan is one of the key document of the risk management process according to ISO 14971:2019; here we present a Risk Management Plan template with the structure of the document already prepared.
The contents of the risk management plan is essential for having an appropriate risk management process, one of the key factor to ensure quality, safety and efficacy of the medical device on the market. With the new EU MDR 2017/745, the interconnection of the risk management process with other quality management system processes such as clinical validation and post-market surveillance became more and more evident and important.
The Risk Management Plan Template that can be downloaded here contains the following sections:
- Scope of the risk management
- Description of the device
- Responsibilities and authorities
- Criteria for risk acceptability
- Evaluation of the overall residual risk
- Verification of the implementation of the risk control measures
- Methods for obtaining relevant post-production information
This risk management plan template is compliant with the following ISO standards related to the risk management process:
- ISO 14971:2019 – Medical devices — Application of risk management to medical devices
- ISO/TR 24971:2020 – Medical devices – Guidance on the Application of ISO 14971
The Risk Management Plan Template contains several parts which are already prepared and written. At the same time, comments and guideline are provided for the parts which need to be filled by the organization (for example the part related to the device object of the risk management activities).
The Risk Management Plan Template, along with the related risk management procedure and the technique for risk analysis already described in the QualityMedDevi blog are an essential tool for risk management activities. Other activities like labelling, post-market surveillance and clinical validation are strictly connected with risk management.
Here at QualityMedDev we have a Risk Management Plan Template fully editable in word that can be used as starting point for the construction of your risk management process, fully compliant with ISO 13485, FDA regulations 21 CFR 820, ISO 14971:2019 and aligned with the EU MDR 2017/745.
Do not hesitate to download the product!
For any questions or inquiries, please contact us : info[at]qualitymeddev.com
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