Risk and Usability: engineering that anticipates errors before the user encounters them.

We structure your device's risk management (ISO 14971:2019) and usability engineering (IEC 62366-1), from planning and risk analysis to the risk management file and formative and summative use studies.

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Risk and Usability: engineering that anticipates errors before the user encounters them.
What we deliver

We integrate risk and usability into the design lifecycle, rather than treating them as standalone documents.

  1. Risk management planning and analysis (FMEA, hazard analysis).

  2. A traceable risk management file (RMF), maintained throughout the lifecycle.

  3. Usability engineering planning and file (UEF).

  4. Formative studies and summative usability validation.

  5. Integration of risk, usability and clinical evaluation.

Deliverables

What you receive

A risk management plan and file (ISO 14971).
Risk analysis (FMEA / hazard analysis).
A usability plan, protocols and reports (IEC 62366-1).
A summative validation report.
References

Reference standards

  • ISO 14971:2019 - application of risk management to medical devices.
  • IEC 62366-1 - usability engineering.
  • Alignment with IEC 60601 (medical electrical equipment), where applicable.
FAQ

Frequently asked questions

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Are your project's risk management and usability files up to date?

We structure both in accordance with ISO 14971 and IEC 62366-1.

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