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Ivan Rueda
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Decks in this class (11)
United States Regulatory Affairs
What does fda stand for and what ...,
What does cfr stand for and what ...,
What is 21 cfr part 820 and what ...
41
cards
European Union Regulatory Affairs
What is the eu mdr and when was i...,
What is the eu ivdr and how does ...,
What does the ce mark signify on ...
28
cards
Health Canada Regulatory Affairs
What is health canada s role in m...,
What legislative framework govern...,
What is a medical device license ...
27
cards
Global Comparative Regulatory Affairs
What is regulatory harmonization ...,
Compare the quality management sy...,
Compare the udi requirements acro...
18
cards
Design Controls & Quality Systems
What are design controls and why ...,
List the key elements of design c...,
What is the difference between de...
10
cards
Clinical Trials & Evaluation
What are the key differences betw...,
What is informed consent in clini...,
What elements must be included in...
10
cards
Labeling & Promotion
What are the general requirements...,
What is the difference between in...,
What is a reasonable patient phys...
10
cards
Post-Market Requirements
What is medical device reporting ...,
What events must be reported unde...,
What are the timeframes for mdr r...
10
cards
Risk Management
What is iso 14971 and what does i...,
Describe the key elements of a ri...,
What is the difference between ha...
10
cards
Regulatory Submissions & Strategy
Blank 1,
What are the typical fda review t...,
What is the fda performance goal ...
41
cards
Best Practices & Game Theory
What are the key elements of an e...,
How should a regulatory affairs m...,
What approaches help with managin...
55
cards
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Regulatory Affairs
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