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Suzanne Wertz
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Decks in this class (15)
EMA and Other Regulatory Bodies (Ch. 1)
What does ema stand for,
When was the ema founded,
What is the primary function of t...
31
cards
History of Regulations (Ch. 2)
When was the eu formed,
What is the benefit of harmonized...,
What is the structure of eu legis...
45
cards
Advertising and Promotion (Ch. 3)
Why is advertising of healthcare ...,
What is the eu advertising regula...,
True false the goal of the mpd is...
35
cards
Enforcement and Competent Authorities (Ch. 4)
What authority is responsible for...,
What authority is responsible for...,
True false relevant competent aut...
21
cards
Regulatory Strategy (Ch. 5)
What is the definition of regulat...,
What are the market consideration...,
What is a benefit of implementing...
13
cards
The New MDR and IVDR (Ch. 6)
What directives does the new eu m...,
What directive does the new eu iv...,
True false some economic operator...
26
cards
The European Medical Devices Legal System (Ch. 7)
What is the treaty on european un...,
What is the treaty on the functio...,
European legislation is moving to...
82
cards
Medical Devices: Legislation and Classification (Ch. 8)
What is the purpose of the medica...,
What is the definition of a medic...,
What is the definition of a medic...
38
cards
In Vitro Diagnostic Medical Devices (Ch. 9)
What are the directive and regula...,
What is the definition of an in v...,
What are the 4 types of ivds unde...
50
cards
General Safety and Performance Requirements and Technical Documentation (Ch. 10)
What are some of the benefits of ...,
What does gspr stand for,
What are the 3 categories of the ...
20
cards
Medical Device Preclinical Testing (Ch. 11)
What is the purpose of preclinica...,
True false preclinical testing co...,
What factors should be considered...
10
cards
Clinical Evaluation and Clinical Investigations (Ch. 12)
What is a clinical evaluation,
Per both mdd and mdr what classes...,
What is the definition of clinica...
28
cards
Medical Device Conformity Assessment Procedure (Ch. 13)
What is the purpose of the confor...,
Who is responsible for ensuring t...,
What are general requirements of ...
18
cards
Medical Device Compliance: Postmarket Requirements (Ch. 14)
What is the definition of a postm...,
What is the medical device vigila...,
What is the intent of the general...
21
cards
Combination Products (Ch. 16)
What determines the regulatory ap...,
How is the following regulated a ...,
How is the following regulated a ...
3
cards
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EU Medical Device Regulations
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