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The Objective

Human Factors Engineering is fundamentally a safety discipline. At Kapstone, we treat HFE as a subset of Risk Management, ensuring that the identification of a use-error leads directly to an engineered design control. By aligning ISO 62366-1 (Usability) with ISO 14971 (Risk Management), we close the loop between human behavior and device safety.

Key Considerations

  • The Use-Risk Connection: We don't just identify "human error"; we categorize use-errors as potential hazards. Our process ensures that every critical task identified in your usability studies is mapped to a risk control in your Quality Management System (QMS).
  • Use-Error as a Design Input: By identifying "known or foreseeable use-errors" early, we turn potential regulatory hurdles into design inputs. This proactive approach prevents expensive "safety debt" and redesigns late in the development cycle.
  • Post-Market Surveillance (PMS) Readiness: Commercialization isn't the end of HFE. We help teams establish a feedback loop where post-market use-data informs the ongoing risk file, satisfying the requirements of the new FDA QMSR and EU MDR.

FAQ

What is the relationship between use-error and risk management in medical devices?

In MedTech, a use-error is a hazard that must be evaluated under ISO 14971. Identifying these errors through ISO 62366-1 allows engineers to implement risk controls, such as physical barriers, software interlocks, or improved labeling, to ensure the device remains safe and effective for the intended user.

 

How does Human Factors Engineering help to manage risk?

HFE helps designers and engineers to understand how users might interact with a device, and identifies where confusion, misuse, or errors could occur. Kapstone can then design the device to reduce those risks. This approach focuses on making devices safer and easier to use while supporting regulatory expectations for risk management.

 

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If Kapstone sounds like the right fit for your business or you have further questions, please reach out to our team.

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