L
Leticia L
Hello!
I am designing a polymer processing machine for my thesis. It must be able to produce long-term implants, and I have not found much information about requirements or qualification procedures for equipment used to manufacture this kind of medical devices (Class IIb in the EU and class 3 in the FDA, I believe)
I have read some parts of the GMPs and the ISO 13485 Standard, but they refer mostly to the process, not the equipment.
Any information regarding this qualification requirements in the EU and/or US regulations, (or design guidelines, if possible) would be really appreciated.
Thank you in advance for your help!
I am designing a polymer processing machine for my thesis. It must be able to produce long-term implants, and I have not found much information about requirements or qualification procedures for equipment used to manufacture this kind of medical devices (Class IIb in the EU and class 3 in the FDA, I believe)
I have read some parts of the GMPs and the ISO 13485 Standard, but they refer mostly to the process, not the equipment.
Any information regarding this qualification requirements in the EU and/or US regulations, (or design guidelines, if possible) would be really appreciated.
Thank you in advance for your help!