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I'm working with a client who has licensed Ear, Nose Throat technology for a Class II device and who plans to sell the device to companies. In a way, he is a distributor, except for the fact that he "owns" the technology via his licensing agreement.
I'm wondering if the client licensing this technology would have to comply with ISO 13485 and to what extent? The device has already undergone FDA approval.
Thanks for any help on this topic.
I'm wondering if the client licensing this technology would have to comply with ISO 13485 and to what extent? The device has already undergone FDA approval.
Thanks for any help on this topic.