Dear All!
My company wants to have an ISO13485 certification, however it is not decided whether the final product will be just a RUO or an IVD and we did not have any formal design yet, we only have a "quick" prototype (no standards followed). I would like to be careful that our (maybe) RUO product is not associated with diagnosis and I´m not sure how to handle having possibly both RUO and IVD products in the future.
For context - We are developing a device with different components based on our DNA manipulation method. These components are: sample receptacle where the sample treatment takes place, and a software guided instrument which enables the user to handle sample treatment with different kind of settings. Our CEO plans that our IVD product will be only the sample receptacle, while the instrument will be just a RUO device.
In my opinion if our sample receptacle will be an IVD then the instrument handling it must be also an IVD of the same classification. Alternatively, if we would like to have a RUO product then both the sample receptacle and the instrument should be just a RUO. Also we should have an SOP for IVD development and another SOP for RUO development to make the differentiation. Do you think this is this correct? In the second case, if we would only have a RUO product under development, can we even be certified for ISO13485?
Looking forward to read your opinions and thank you for your support!
My company wants to have an ISO13485 certification, however it is not decided whether the final product will be just a RUO or an IVD and we did not have any formal design yet, we only have a "quick" prototype (no standards followed). I would like to be careful that our (maybe) RUO product is not associated with diagnosis and I´m not sure how to handle having possibly both RUO and IVD products in the future.
For context - We are developing a device with different components based on our DNA manipulation method. These components are: sample receptacle where the sample treatment takes place, and a software guided instrument which enables the user to handle sample treatment with different kind of settings. Our CEO plans that our IVD product will be only the sample receptacle, while the instrument will be just a RUO device.
In my opinion if our sample receptacle will be an IVD then the instrument handling it must be also an IVD of the same classification. Alternatively, if we would like to have a RUO product then both the sample receptacle and the instrument should be just a RUO. Also we should have an SOP for IVD development and another SOP for RUO development to make the differentiation. Do you think this is this correct? In the second case, if we would only have a RUO product under development, can we even be certified for ISO13485?
Looking forward to read your opinions and thank you for your support!
