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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28,903
newbean2
Marc
  • Sticky
Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
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1
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5,585
Stijloor
Marc
  • Sticky
The US's FDA and other Medical Device Related Forums
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0
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7,104
Marc
Discussions
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Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019
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5
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209
yodon
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ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks"
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2
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302
mihzago
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Clinical research - Request from ANVISA
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1
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160
Ghisana F
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Normal Condition Hazards in Risk Analysis
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3
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220
silentmonkey
silentmonkey
How to measure severity if my product is designed for emergency use and failure would result in death?
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9
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457
silentmonkey
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Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs
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18
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2,427
marmotte
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Sample Procedure from Contract Manufacturer Prospective
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1
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186
yodon
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Practical Implementation of ISO 14971
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6
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480
Jen Kirley
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Gap analysis on ISO 14971:2019 with previous revision
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3
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765
MDRexpert
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Supplier Audits in the wake of COVID-19
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3
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582
LauraConstantinescu
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Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management
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5
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583
Regulatory
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New ISO 14971:2019 Harm: unreasonable psychological stress, and cybersecurity
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13
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853
Tidge
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ISO 14971 PFMEA Manufacturing Risk
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2
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341
levatorsuperioris
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Overall residual risk according to ISO 14971:2019
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5
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554
KrisD
adir88
Documenting Risk Control Option Analysis
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8
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634
cbartlett
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