Quality Assurance and Selection Flashcards
1
Q
Who is responsible for the selection of an appropriate material ?
A
Registrant
2
Q
What regulates the materials that come to market?
A
Medical devices directive
3
Q
If the assessment if favourable, what will be awarded?
A
CE mark
4
Q
What does a CE mark establish?
A
good manufacturing practices are followed and components are traceable from source to end product
5
Q
What is compliance regulated by?
A
International Standards Organisation
6
Q
What is used to classify the risks of the dental material?
A
Product standard compliance
