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.