The risk management part in the design phase of the final finished product, only the intended user can verify the risk mitigation and validate the safe use of the design. The Usability Engineering (UE) validation and risk mitigation affected by the device design and user manual has resulted in an increased need for Usability Engineering Studies per IEC 60601-1-6.
*ISO/IEC 60601-1-6:2010 Usability: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
Please contact our FDA 510(k) Consultant for further information about theUsability Engineering Studies. We may be able to assist you.
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