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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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IEC 62366 - Medical Device Usability Engineering
Application of usability (human factors engineering) engineering to medical devices.
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IEC 62366:2015 Annex C - changed parts from 5.1-5.8 --> but what about 5.9?
Tobias_HF
Sep 2, 2016
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3
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6K
Sep 2, 2016
Tobias_HF
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EU Useability Study for FDA? Class II Medical Device
Frodeno
Aug 15, 2016
2
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10
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5K
Aug 30, 2016
Tobias_HF
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New MHRA guidance on Human Factors - Usability Engineering
Marcelo
Jun 10, 2016
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1
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4K
Jun 10, 2016
SteveK
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BSI White Paper on Human Factors/Usability Engineering
Lerotronic
Jun 12, 2015
2
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12
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8K
Jun 23, 2015
Marcelo
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Detectability score in a use-related FMEA
ET_Marley
Sep 20, 2012
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5
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8K
May 4, 2015
pgk_94566
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Application of IEC 62366 - Usability of Non-Active Medical Devices
Chrisx
Feb 6, 2013
2
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15
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12K
Dec 29, 2014
Ronen E
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Medical Device Design Verification Testing - Is ISO 62366:2008 what I'm looking for?
ApaDan
Jan 5, 2010
2
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16
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18K
Aug 7, 2014
StojanovicM
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Medical Device supplemented with a Mobile Application
elmagnifico
Jun 13, 2014
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4
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4K
Jun 16, 2014
elmagnifico
E
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FDA officially recognizes HE75 Human Factors Standard
Factoring Humans
Oct 27, 2010
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8
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11K
May 18, 2014
Quality Julie
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Final Validation Unit Requirements - Annex D of IEC 62366
zinzibars
Mar 9, 2014
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6
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5K
Mar 25, 2014
frivolas
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"Labeling" vs "Accompanying Documentation" - FDA Definitions
frivolas
Mar 12, 2014
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2
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5K
Mar 12, 2014
yodon
Y
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Problems with the application of EN 62366:2008
S. Costa
Oct 27, 2011
2
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13
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9K
Sep 13, 2013
Pads38
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Should Intentional Misuse be covered in the Risk Analysis under ISO 62366?
alexeyb
Nov 9, 2012
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3
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3K
May 2, 2013
S. Costa
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Number of Participants - Usability Validation
pmollem
Feb 15, 2013
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3
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5K
Feb 16, 2013
pmollem
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IEC 62366 for Stand-Alone Medical Device Software and Usability Engineering
sparvhok
Jan 31, 2012
2
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16
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13K
Nov 15, 2012
Shibukallidukkil
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