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.
FAQs
M
ISO 14971 Medical Device Risk Management FAQ
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newbean2
Marc
  • Sticky
Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
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5,084
Stijloor
Marc
  • Sticky
The US's FDA and other Medical Device Related Forums
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6,518
Marc
Discussions
adir88
Documenting Risk Control Option Analysis
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402
cbartlett
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New 14971:2019 Harm: unreasonable psychological stress, and cybersecurity
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272
yodon
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Where does "as far as possible" stop? FMEA - EN 14971
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29
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2,344
cbartlett
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How do you define your Hazards? <a Risk Management discussion>
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780
Bill Hansen
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Can PFMEA be used in disposition of NC material?
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194
Bev D
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Informational ISO 24971:2020 Released
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128
Jean_B
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Risk managment report of Surgical Mask Example
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446
Marco83
MrTetris
Unacceptable risk and information for safety
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975
stealthdog
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Safety Assurance Case Report Format
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107
dore_m
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ECG Risk Analysis Standards
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210
primavesvera
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Where does FMEA fit in your ISO 14971 Risk Management process?
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2,969
Achilleas
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ISO 14971 Applied to Software
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257
yodon
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Should volume of sales be factored into risk probability assessments?
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33
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1,255
Dr. IJ Arora
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Design FMEA - Detection Rating criteria
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262
John Predmore
MrTetris
Should potential bugs be considered in software risk analysis?
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5
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325
MrTetris
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