IEC 62366 - Medical Device Usability Engineering

Application of usability (human factors engineering) engineering to medical devices.
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Essential MDR documents
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pseudoazurin
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Summative evaluation: how many sample per participant?
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shpponer
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Is formulative testing always required
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yodon
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Usability Objectives and Verification & Validation Plan
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Haresh
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European Harmonized vs IEC standard
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Balamurugan B
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Usability for custom made medical devices
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Koskis
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How do Functions & Tasks differ?
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Tidge
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User Interface of Unknown Provenance (UOUP) applicability
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FrozenJay
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Does anyone have experience with EN ISO 17664 ?
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monoj mon
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Primary Operating Functions (POF) in IEC 62366-1:2015.
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Tidge
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Assessing Hazard-Related Use Scenarios where control measures exist through standards
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ThatSinc
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adir88
Amendment 1 of IEC 62366-1 - Details yet?
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adir88
adir88
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Applicability of IEC 62366-1 usability to resorbable bone substitutes
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Tobias_HF
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IEC 60601-1-6 last release or IEC 62366?
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Belen Sanchez
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pashah
Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6
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pashah
pashah
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