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Hi Guys ,
i need your input regarding Biocompatibility testing on a medical device, whats need to be consider . we have to follow the ISO10993 for the selection of the test. My questions is that
If all the material which used to manufacture a madical device are biocompatible according to the certificates provided by the supplier . Is is enough to comply with the requirement or do we have to once again perform all the tests on finished device.
most of our component are USP calss VI compatible. do we have to test the finished product or the component as well if they are not biocompatible.
what happen to the component who don,t ave any certificate of conformity from supplier . do we have to perform biocompatibility testing on these component before use them in production?
Thanks in advance
i need your input regarding Biocompatibility testing on a medical device, whats need to be consider . we have to follow the ISO10993 for the selection of the test. My questions is that
If all the material which used to manufacture a madical device are biocompatible according to the certificates provided by the supplier . Is is enough to comply with the requirement or do we have to once again perform all the tests on finished device.
most of our component are USP calss VI compatible. do we have to test the finished product or the component as well if they are not biocompatible.
what happen to the component who don,t ave any certificate of conformity from supplier . do we have to perform biocompatibility testing on these component before use them in production?
Thanks in advance
