S
shalom1234
We're a young start-up medical device company, and we develop a blood-contact long-term implant. We're evaluating materials to use in our product and should prepare for most stringent biocompatibility evaluation per ISO 10993.
Our suppliers suggest USP Class IV compliance documentation, and general statements regarding "medical-grade" and "biocompatibility", which are not concrete nor relevant to ISO 10993.
We're looking for polymer (PTFE, PVC etc.) to construct the device, and we're trying to get some information to make our initial selection of materials.
Any suggestion on possible biocompatible materials that we should evaluate?
any suggestion on what to ask the suppliers to improve the biocompatibility evaluation?
Thanks!
Our suppliers suggest USP Class IV compliance documentation, and general statements regarding "medical-grade" and "biocompatibility", which are not concrete nor relevant to ISO 10993.
We're looking for polymer (PTFE, PVC etc.) to construct the device, and we're trying to get some information to make our initial selection of materials.
Any suggestion on possible biocompatible materials that we should evaluate?
any suggestion on what to ask the suppliers to improve the biocompatibility evaluation?
Thanks!