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Hi, I hope you can just help me out here - We have a medical device that we are going to attach sensors to which will then link to some software. As well as the product having to conform to the requirements of ISO13485 and the medical devices directive for CE marking. Does anyone know what software regulations I will need to comply with if any and also is there an invivo diagnostic regulation. I dont mean invitro, as the test will be done whilst the device is in the human body. Finally, does anyone know the definition of "an active implantable device" as I dont have a copy of the ISO14708 and I am not sure whether we need to go this route anyway. OK thanks in advance for any help that is forthcoming. Great site by the way.........