W
WisdomseekerSC
If we had lots of money or diverted the cost to the customer, we could do lots of testing for biocompatibility. However, we would like to provide customers with implantable component parts that don't cost "an arm and a leg" (this is figuratively speaking of course) or utilize any more test animals than are absolutely necessary.
We currently do USP Class VI plastics testing and no ISO 10993. As a contract manufacturer of non-sterile implantable material, what biocompatibility testing responsibilities do we need to assume? Are these testing requirements primarily meant for finished devices or component manufacturers too? From a risk perspective, we want to market our material for use in implantable devices? Are non-sterile absorbable implantable materials (contacting tissue/bone and blood for > 30 days) viewed any different from a testing perspective?
Lots of questions for a Monday morning. Fiscal responsibilities vs risk assumption is the hot topic for me today. How do the experts confront these issues?
We currently do USP Class VI plastics testing and no ISO 10993. As a contract manufacturer of non-sterile implantable material, what biocompatibility testing responsibilities do we need to assume? Are these testing requirements primarily meant for finished devices or component manufacturers too? From a risk perspective, we want to market our material for use in implantable devices? Are non-sterile absorbable implantable materials (contacting tissue/bone and blood for > 30 days) viewed any different from a testing perspective?
Lots of questions for a Monday morning. Fiscal responsibilities vs risk assumption is the hot topic for me today. How do the experts confront these issues?