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.
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As part of Risk Analysis, we ...
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Define the intended use of the product and identify device-safety characteristics
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Identify potentially hazardous use scenarios
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Estimate risk(s) for each hazardous situation
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As part of Risk Control, we...
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Conduct risk control option analysis
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Implement risk control measure(s)
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Evaluate residual risks
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Conduct risk/benefit analysis
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Identify risks arising from risk control measures
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Confirm the completeness of risk control
