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