R
Dear all,
I'm a new member and I'm looking for your help!
My product is a spinal cage, a device that will be implanted in bone for more than 30 days. It will be in a composite material with PLA (resorbable). So I should perform the following test:
- cytotoxicity
- sensilization
- irritation
- systemic toxicity
- subacute and subcronic toxicity
- genotoxicity
- implantation
- chronic toxicity
- carcinogenicity
- biodegradation.
The company that will manufacture the cage for my company has already obtained the approval for the CE mark for a cage in the same composite (they will manufacture my cage also in the same way). However this cage has a different shape and different size compared with my cage (in particular it is smaller than mine).
In your opinion I could skip out some tests exploiting the likeness with this cage or not? I know that one could in general follow the "literature route" ...
Thanks for all the help you'll give me.
Rossella
I'm a new member and I'm looking for your help!
My product is a spinal cage, a device that will be implanted in bone for more than 30 days. It will be in a composite material with PLA (resorbable). So I should perform the following test:
- cytotoxicity
- sensilization
- irritation
- systemic toxicity
- subacute and subcronic toxicity
- genotoxicity
- implantation
- chronic toxicity
- carcinogenicity
- biodegradation.
The company that will manufacture the cage for my company has already obtained the approval for the CE mark for a cage in the same composite (they will manufacture my cage also in the same way). However this cage has a different shape and different size compared with my cage (in particular it is smaller than mine).
In your opinion I could skip out some tests exploiting the likeness with this cage or not? I know that one could in general follow the "literature route" ...
Thanks for all the help you'll give me.
Rossella