Applied ISO14971 Medical Device Risk Management
A concise guide to executing ISO 14971 requirements
4.30 (945 reviews)
2 517
students
2.5 hours
content
Sep 2017
last update
$129.99
regular price
What you will learn
Understand the ISO14971 medical device risk management requirements and sequence
Understand the roles and responsibilities of a risk management team
Construct a risk management plan
Apply the FMEA and 5×5 matrix in risk analysis
Understand the relationship between risk evaluation, risk control and medical device testing
Iterate the risk management process to evaluate residual risks
Use risk/benefit analysis to assess residual risks
Apply the Fault-Tree and Event Tree Analysis to evaluate residual risks
Understand the importance of the risk management file
Understand the type of post-production information required
Dealing with unforeseeable risks in risk evaluation
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759420
udemy ID
11/02/2016
course created date
12/04/2021
course indexed date
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