I am currently starting a project in the biomedical field with the 3D printing technology.
As everyone knows, the medical field is highly regulated!
That is why I am looking for filament already certified biocompatible (specially ISO10993-1, but also USP VI, and why not FDA). I just need to be sure that the filament respect the class 1 of the medical devices classification. I have found so much brands of filaments on the web (Stratasys, Taulmann, Colorfabb, … and if you are aware of better brands, feel free to share them).
But I still have some questions and I don’t know where to find the answers:
- if I have a certificated filament but then I use my FDM 3D printer (that is not), will the filament be still certificate and with no risk for the patient ? or should I certificate the 3D printer too ?
The material will still be the same, but just heated and molded… Until what point can we “modify/transform” the material to keep the certification valid?
- What is the difference between a machine certification (3D printer) and a material certification (filament) ?
- if I have to certificate the whole process, should I follow the ISO13485 norm?
Thank you very much for your help