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
Marcelo Antunes
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ISO 14971 Medical Device Risk Management FAQ
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38
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24,240
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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3,489
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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5,008
Marc
Discussions
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ISO 14971 Risk Management - Questions for Hazard identification
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sriramsl
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More than one Risk Report per Medical Device
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3
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190
ywwang15
Marcelo Antunes
ISO 14971 and ISO TR 24971 revision
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25
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6,342
blah01
Marcelo Antunes
ISO 14971 Risk Management questions and comments
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38
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16,568
Jean_B
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PMS Competitor Device product data from (MAUDE or TPLC)
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3
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383
Valerie Bennett
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Doing both a top-down and a bottom-up risk assessment - How to combine
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6
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313
indubioush
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An auditor asked for a Post Market Surveillance Report
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4
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1,475
pavel
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Grouping of Products for Risk Analysis
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9
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365
BenBurk
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Necessity of external watchdog next to internal watchdog
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162
Hemanth Kumar
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Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs?
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2
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275
Developer_Germany
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The difference b/w FMEA & Risk analysis as per iso 14971
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6
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593
Ronen E
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Risk Benefit Analysis - ISO 14971:2012 Requirements
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27
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7,945
Peter Selvey
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Examples of inherent safety by design
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21
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2,053
Marcelo Antunes
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Risk management according to ISO 14971 - When to document risk controls?
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10
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698
Tiago Alfenas
FoGia
IMDRF opened a Consultation on Annex E & F and the link to ISO 14971
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4
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838
Lerotronic
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