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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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ISO 14971 Medical Device Risk Management FAQ
Marcelo Antunes
Feb 10, 2012
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38
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24,792
Dec 20, 2018
newbean2
Sticky
Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
Marc
Sep 16, 2014
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3,689
Sep 19, 2014
Stijloor
Sticky
The US's FDA and other Medical Device Related Forums
Marc
Oct 18, 2009
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5,192
Oct 18, 2009
Marc
Discussions
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Examples of inherent safety by design
Roland chung
May 28, 2018
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2,442
58 minutes ago
Tidge
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Risk Reduction by Risk Control: IEC:62304-Class C
Kleibeuker
May 2, 2017
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4,508
Yesterday at 8:34 AM
Tidge
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Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs
akp060
May 21, 2019
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780
Aug 29, 2019
Marcelo Antunes
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Fire hazard classification - Clause in IEC 60601 about gauze and electricity
AbelVV
Aug 29, 2019
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Aug 29, 2019
AbelVV
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Risk Management selection Probability of Occurrence and Severity
eileenr
Jul 12, 2013
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6,548
Aug 27, 2019
Gardenia
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ISO 14971 Risk Management - Questions for Hazard identification
sriramsl
Aug 3, 2019
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376
Aug 6, 2019
sriramsl
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More than one Risk Report per Medical Device
bigsisj91
Jul 25, 2019
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Jul 28, 2019
ywwang15
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ISO 14971 and ISO TR 24971 revision
Marcelo Antunes
Jan 27, 2017
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6,750
Jul 24, 2019
blah01
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ISO 14971 Risk Management questions and comments
Marcelo Antunes
Mar 18, 2009
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16,767
Jul 5, 2019
Jean_B
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PMS Competitor Device product data from (MAUDE or TPLC)
Jnks_Meddev
Feb 11, 2019
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471
Jun 15, 2019
Valerie Bennett
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Doing both a top-down and a bottom-up risk assessment - How to combine
david316
Jun 5, 2019
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419
Jun 7, 2019
indubioush
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An auditor asked for a Post Market Surveillance Report
SpartanBio
Feb 23, 2018
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Jun 6, 2019
pavel
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Grouping of Products for Risk Analysis
BenBurk
May 24, 2019
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432
May 26, 2019
BenBurk
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Necessity of external watchdog next to internal watchdog
Do ya like dags?
May 21, 2019
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192
May 24, 2019
Hemanth Kumar
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The difference b/w FMEA & Risk analysis as per iso 14971
RUBI
Mar 22, 2019
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728
May 20, 2019
Ronen E
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