Remediation of Risk File according to ISO 14971

  • The Problem

    The customer needed to remedediate the Risk Files of Implantable class IIb device and Instruments to be compliant with the EN ISO 14971:2012 standard.

    Our Solution

    We perform a gap analysis of existing documentation. We define and implement a new SOP and process. We worked with the client to remediate and improve the existing documentation.

  • Our Results

    Compliant documentation and improved Risk Management process.

    100%
    Quick Service
    100%
    Customer Satisfaction

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