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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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ISO 14971 - Medical Device Risk Management
ISO 14971 - Medical Device Risk Management and Hazard Control: Identifying and controlling the risks and the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices.
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FAQs
M
Sticky
ISO 14971 Medical Device Risk Management FAQ
Marcelo
Feb 10, 2012
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4
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38
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26,591
Dec 20, 2018
newbean2
Sticky
Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
Marc
Sep 16, 2014
Replies
1
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4,525
Sep 19, 2014
Stijloor
Sticky
The US's FDA and other Medical Device Related Forums
Marc
Oct 18, 2009
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0
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5,997
Oct 18, 2009
Marc
Discussions
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ISO 14971:2012 - Verification of Implementation of Risk Control Measures
Maire
Feb 18, 2014
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12
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6,173
Mar 19, 2020
Ronen E
Tools for Normal and Fault Conditions
adir88
Mar 10, 2020
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8
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160
Mar 12, 2020
indubioush
Information of safety can reduce risk now?
adir88
Mar 10, 2020
Replies
5
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144
Mar 11, 2020
Ronen E
MDR requirement: Risk Management Plan for "each device"
adir88
Feb 27, 2020
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306
Mar 11, 2020
Verna
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Attachment browser
ISO 14971 and ISO TR 24971 revision
Marcelo
Jan 27, 2017
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32
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8,802
Mar 9, 2020
Ronen E
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Does anybody use Detection in medical device Design FMEA?
indubioush
Feb 24, 2020
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18
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783
Mar 5, 2020
indubioush
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EN ISO 14971:2019 does not include the Annex Zs
ASteel
Feb 20, 2020
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295
Feb 26, 2020
blackholequasar
IVD manufacturer and service provider
samarth
Feb 17, 2020
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2
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167
Feb 21, 2020
indubioush
Informational
What's new in ISO 14971:2019
Ronen E
Jan 23, 2020
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2
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543
Feb 11, 2020
Sam Lazzara
How to qualitatively assess initial probability
MrTetris
Feb 4, 2020
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175
Feb 4, 2020
Ronen E
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The difference b/w FMEA & Risk analysis as per iso 14971
RUBI
Mar 22, 2019
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1,235
Jan 31, 2020
indubioush
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ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable
Teyla
Jan 23, 2020
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516
Jan 29, 2020
InSituTech
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Performance specification as a Risk Control Measure, EN 14971
DamienL
Jan 7, 2020
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448
Jan 22, 2020
akp060
Unacceptable risk and information for safety
MrTetris
Dec 17, 2019
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631
Jan 20, 2020
MrTetris
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Where does "as far as possible" stop? FMEA - EN 14971
DamienL
Dec 18, 2019
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1,183
Jan 20, 2020
akp060
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