Risk Management

We manage risk throughout the design workflow - applying the ISO 14971-1-2012-standards-based approach to risk management.

Following this standard enables us to establish risk management requirements and to use these during the product life cycle to determine the safety of a manufacturer’s product (particularly for medical device safety).

ISO 14971 is a nine-part standard that first establishes a framework for risk analysis, evaluation, control, and management, and also specifies a procedure for reviewing and monitoring during production and post-production.

As part of Risk Analysis, we …

  • Define the intended use of the product and
    identify device-safety characteristics
  • Identify potentially hazardous use scenarios
  • Estimate risk(s) for each hazardous situation

As part of Risk Control, we…

  • Conduct risk control option analysis
  • Implement risk control measure(s)
  • Evaluate residual risks
  • Conduct risk/benefit analysis
  • Identify risks arising from risk control measures
  • Confirm the completeness of risk control
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