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

 

Aproio: we analyze, design, build & test medtech and other highly reglated products
Risk Management