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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.
FAQs
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ISO 14971 Medical Device Risk Management FAQ
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38
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30,461
newbean2
Marc
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Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
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1
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6,249
Stijloor
Marc
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The US's FDA and other Medical Device Related Forums
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0
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7,741
Marc
Discussions
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Risk Management Review
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4
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142
yodon
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Risk Management selection Probability of Occurrence and Severity
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24
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8,190
qualprod
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When is a hazardous situation?
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14
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355
indubioush
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Risk Management and other Files
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8
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234
yodon
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RPN Thresholds and How Detection Fits In
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5
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201
yodon
silentmonkey
Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation
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3
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262
FoGia
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Missing 1m visual alarm signal in case of software/display failure, mitigation?
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3
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179
purplehaze
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Risks arising from control measures vs. ineffective control measures
2
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11
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422
indubioush
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ISO 14971:2019: Criteria for overall residual risk
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4
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626
Moricona
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ISO 14971 Determination of Competent Persons
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4
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322
Jean_B
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Risk Matrix vs FMEAs
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3
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314
Tidge
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ISO14971:2019 - Verification of implementation and effectiveness of risk control
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3
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314
ThatSinc
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Setting flexible packaging specification limits
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4
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345
Tidge
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Risk control measures as per ISO 14971
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6
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635
Regulatory
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Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019
2
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10
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1,148
Molle
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