Risk Management

Risk management is a critical process for medical devices. We assist in implementing ISO 14971:2019 compliant risk management processes throughout the product lifecycle.

Risk Management activities:

  • Risk Management Plan
  • Hazard Analysis
  • FMEA (Design and Process)
  • Risk-Benefit Analysis
  • Risk Management Report
  • Production and Post-Production Information
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Application of Risk Management to Medical Devices

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Clinical Evidence — IVDR

Under IVDR Article 56 - clinical data and performance evaluation results for device safety assessment.

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