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
Marcelo Antunes
  • Sticky
ISO 14971 Medical Device Risk Management FAQ
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38
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22,113
newbean2
Marc
  • Sticky
Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
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1
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3,036
Stijloor
Marc
  • Sticky
The US's FDA and other Medical Device Related Forums
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0
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4,655
Marc
Discussions
J
Software for Techfiles and Risk management
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72
yodon
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Risk Analysis Updates due to complaints
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196
Kjb78
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Where does FMEA fit in your ISO 14971 Risk Management process?
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11
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349
Jean_B
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The Severity of a Medical Device Hazard - Risk Analysis Clarification
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6
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220
subbash
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PMS Competitor Device product data from (MAUDE or TPLC)
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2
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60
yodon
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Information for safety EN ISO 14971:2012 - Customer Risk Reduction
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2
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129
mihzago
M
Labelling and the harmonized EN ISO 14971:2012
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9
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2,812
subbash
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Should there be a SOP on Cybersecurity?
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1
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136
Ajit Basrur
MrTetris
Informational Risk Register - Same hazardous situation, different severity of harms
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7
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381
Peter Selvey
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How to Validate Effectiveness of Mitigations?
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13
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4,601
Peter Selvey
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Medical Device Cybersecurity Risk Management File
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2
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195
pmg76
Marcelo Antunes
ISO 14971 and ISO TR 24971 revision
2
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16
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5,127
Marcelo Antunes
Marcelo Antunes
Future of ISO 14971 - Possible revision?
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9
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2,447
Marcelo Antunes
Marcelo Antunes
The future of ISO 14971:2007
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2
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1,028
Marcelo Antunes
E
Risk Analysis - Events which may cause to Data Loss
2
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12
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2,733
Peter Selvey
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