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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.

FAQs
Marcelo Antunes
  • Sticky
ISO 14971 Medical Device Risk Management FAQ
2 3 4
Replies
38
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22,791
newbean2
Marc
  • Sticky
Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines?
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1
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3,117
Stijloor
Marc
  • Sticky
The US's FDA and other Medical Device Related Forums
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0
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4,704
Marc
Discussions
R
The difference b/w FMEA & Risk analysis as per iso 14971
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1
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163
Marcelo Antunes
D
Risk management according to ISO 14971 - When to document risk controls?
2
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10
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366
Tiago Alfenas
J
Software for Techfiles and Risk management
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2
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235
Timothea
FoGia
IMDRF opened a Consultation on Annex E & F and the link to ISO 14971
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4
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645
Lerotronic
K
Risk Analysis Updates due to complaints
2
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10
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448
Kjb78
D
Where does FMEA fit in your ISO 14971 Risk Management process?
2
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11
Views
782
Jean_B
S
The Severity of a Medical Device Hazard - Risk Analysis Clarification
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6
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361
subbash
J
PMS Competitor Device product data from (MAUDE or TPLC)
Replies
2
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112
yodon
Q
Information for safety EN ISO 14971:2012 - Customer Risk Reduction
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2
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223
mihzago
M
Labelling and the harmonized EN ISO 14971:2012
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9
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2,972
subbash
S
Should there be a SOP on Cybersecurity?
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1
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198
Ajit Basrur
MrTetris
Informational Risk Register - Same hazardous situation, different severity of harms
Replies
7
Views
503
Peter Selvey
A
How to Validate Effectiveness of Mitigations?
2
Replies
13
Views
4,744
Peter Selvey
S
Medical Device Cybersecurity Risk Management File
Replies
2
Views
246
pmg76
Marcelo Antunes
ISO 14971 and ISO TR 24971 revision
2
Replies
16
Views
5,413
Marcelo Antunes
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