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.
Forum FAQ Threads
Marcelo Antunes
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ISO 14971 Medical Device Risk Management FAQ
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20,841
Marcelo Antunes
Marc
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Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
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2,913
Stijloor
Marc
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The US's FDA and other Medical Device Related Forums
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4,556
Marc
Forum Discussion Threads
Marcelo Antunes
ISO 14971 and ISO TR 24971 revision
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4,333
Marcelo Antunes
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Risk Analysis - Events which may cause to Data Loss
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leichu83
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How to Document Risk Effects on Design Change(s)
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252
Marcelo Antunes
FoGia
IMDRF opened a Consultation on Annex E & F and the link to ISO 14971
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210
FoGia
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Risk-based Design
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Timothea
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Labelling and the harmonized EN ISO 14971:2012
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2,362
Marcelo Antunes
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Design Control Assistance required
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420
Woodray
Marcelo Antunes
Example ISO 14971 policy and risk criteria
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504
Marcelo Antunes
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Risk Matrix used by my company
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Soogwoog
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Is the RPN (risk priority number) in the PFMEA really a RPN without the detectability
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4
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544
Marcelo Antunes
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