Medical Devices: From Concept to Reality Flashcards
1
Q
what are the seven important things that need to be considered when creating a successful medical device?
A
- market reguirements
- system design
- money, time and performance
- internal negotiation
- verification
- validation
- market success
2
Q
design control=…
A
regulatory recipe for product development
3
Q
what is the primary goal of medical device regulation?
A
the protection of public health and safety by ensuring the quality, safety and efficiacy of the medical devices generally available for the treatment of the general public
4
Q
what the the penalties for failing to meet medical device regulation?
A
- fines
- imprisonment
5
Q
what are the goals of effective design control?
A
time to market
superior product
lower cost of product
regulatory compliance
6
Q
what are the considerations in product development?
A
performance
time
product cost
development cost
