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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
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ISO 14971 Medical Device Risk Management FAQ
Marcelo
Feb 10, 2012
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25,797
Dec 20, 2018
newbean2
Sticky
Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
Marc
Sep 16, 2014
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4,157
Sep 19, 2014
Stijloor
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The US's FDA and other Medical Device Related Forums
Marc
Oct 18, 2009
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5,646
Oct 18, 2009
Marc
Discussions
Unacceptable risk and information for safety
MrTetris
Dec 17, 2019
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Today at 9:28 AM
MrTetris
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Where does "as far as possible" stop? FMEA - EN 14971
DamienL
Dec 18, 2019
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Today at 1:38 AM
akp060
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An example of risk analysis of class I MD
Marco83
Nov 6, 2019
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1,273
Wednesday at 9:58 PM
Ronen E
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ISO 14971 and ISO TR 24971 revision
Marcelo
Jan 27, 2017
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Tuesday at 11:38 PM
Ronen E
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Performance specification as a Risk Control Measure, EN 14971
DamienL
Jan 7, 2020
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248
Jan 8, 2020
Jean_B
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When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019?
YellowQCPro
Dec 19, 2019
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Dec 19, 2019
Ronen E
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Risk Analysis & Technical File - What detail goes in the Risk Management Report
Dobby1979
Dec 3, 2019
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Dec 3, 2019
Ronen E
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Examples of inherent safety by design
Roland chung
May 28, 2018
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Nov 6, 2019
Ronen E
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Identifying Hazards - Risk management process
mf389
Nov 1, 2019
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Nov 4, 2019
Tidge
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Risk Management in the Medical Device Industry
racglobal
Oct 24, 2019
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Oct 27, 2019
Marcelo
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Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs
akp060
May 21, 2019
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Oct 21, 2019
Tidge
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Bottom up approach versus system level
racglobal
Oct 18, 2019
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Oct 21, 2019
Tidge
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Risk Reduction by Risk Control: IEC:62304-Class C
Kleibeuker
May 2, 2017
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Oct 18, 2019
Tidge
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Fire hazard classification - Clause in IEC 60601 about gauze and electricity
AbelVV
Aug 29, 2019
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Aug 29, 2019
AbelVV
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Risk Management selection Probability of Occurrence and Severity
eileenr
Jul 12, 2013
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6,790
Aug 27, 2019
Gardenia
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