Risk Management

Your Risk Management Process is the foundation on which your devices’ safety and performance are maintained throughout their life cycle.

Working with you we develop and document your Risk Management Process to meet the requirements of ISO 14971 and specific national regulations.

Using our experience we provide support to prepare, implement and maintain your Risk Management System embracing:

  • Risk Management Plan(s) from device design to use, re-use and disposal

  • Initiate and update Risk Management File(s)

  • Defined, proven methodologies and process(es) for;

    • Usability & Human Factors
    • Hazard Identification
    • Risk Assessment and Risk Analyses
    • Benefit Risk appraisal
    • Risk Acceptance
    • Risk Management Report(s)
    • Data Analyses

We provide training in Risk Management for Medical Devices (see Training).

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