Lecture 2 Flashcards
1
Q
“Medical Device”
A
any instrument, apparatus, appliance, software, implant, reagent, material or other article internded by the manufacturer to be used for specific medical purpose
2
Q
What are the parts of “Post-market surveillance”?
A
- Risk management
- Clinical evaluation
3
Q
What is the product development process?
A
User needs
Design input
Design output
Process input
Process output
Process verification/validation
4
Q
What is the name of the model for the development process?
A
The V-model
