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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.

Aproio: we analyze, design, build & test medtech and other highly reglated products
Aproio: we manage risk throughout the development process compliant with ISO standards

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

Risk Management
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