The management of risks became an essential part of any quality system and having a dedicated procedure in place is essential for medical device companies. This is especially true for the design process and the application of ISO 14971.
Furthermore, the application of a risk-based approach is nowadays the standard practice for any quality systems.
Here at QualityMedDev we show an example of risk management procedure, fully compliant with ISO 14971 version 2019. The document explains the implementation of the whole risk-related activities, including the new requirements of risk management review and production&post-production feedback, with full integration of the new post-market surveillance requirements.
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For any questions or inquiries, please contact us : info[at]qualitymeddev.com