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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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Sticky
ISO 14971 Medical Device Risk Management FAQ
Marcelo
Feb 10, 2012
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4
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38
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30,461
Dec 20, 2018
newbean2
Sticky
Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
Marc
Sep 16, 2014
Replies
1
Views
6,249
Sep 19, 2014
Stijloor
Sticky
The US's FDA and other Medical Device Related Forums
Marc
Oct 18, 2009
Replies
0
Views
7,741
Oct 18, 2009
Marc
Discussions
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Risk Management Review
Seekingknowledgee
Thursday at 2:00 PM
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4
Views
142
Friday at 9:27 AM
yodon
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Risk Management selection Probability of Occurrence and Severity
eileenr
Jul 12, 2013
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3
Replies
24
Views
8,190
Feb 27, 2021
qualprod
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When is a hazardous situation?
ThatSinc
Feb 18, 2021
2
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14
Views
355
Feb 26, 2021
indubioush
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Risk Management and other Files
Seekingknowledgee
Feb 24, 2021
Replies
8
Views
234
Feb 25, 2021
yodon
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RPN Thresholds and How Detection Fits In
tammyfromri
Feb 12, 2021
Replies
5
Views
201
Feb 12, 2021
yodon
Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation
silentmonkey
Feb 9, 2021
Replies
3
Views
262
Feb 12, 2021
FoGia
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Missing 1m visual alarm signal in case of software/display failure, mitigation?
purplehaze
Jan 26, 2021
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3
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179
Jan 27, 2021
purplehaze
T
Risks arising from control measures vs. ineffective control measures
ThatSinc
Jan 6, 2021
2
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11
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422
Jan 26, 2021
indubioush
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ISO 14971:2019: Criteria for overall residual risk
mithilesh
Jan 7, 2021
Replies
4
Views
626
Jan 22, 2021
Moricona
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ISO 14971 Determination of Competent Persons
maxalmill
Jan 19, 2021
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4
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322
Jan 21, 2021
Jean_B
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Risk Matrix vs FMEAs
contigo123
Jan 15, 2021
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3
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314
Jan 15, 2021
Tidge
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ISO14971:2019 - Verification of implementation and effectiveness of risk control
mithilesh
Jan 6, 2021
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3
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314
Jan 7, 2021
ThatSinc
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Setting flexible packaging specification limits
binfo
Dec 21, 2020
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4
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345
Dec 24, 2020
Tidge
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Risk control measures as per ISO 14971
Regulatory
Nov 28, 2020
Replies
6
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635
Dec 1, 2020
Regulatory
B
Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019
bolesen
Oct 19, 2020
2
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10
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1,148
Nov 21, 2020
Molle
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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