S
Hi all,
Our company produces and distributes medical devices under our name and we are also doing product development and production for another company (company B).
If we choose to go according to Annex IX for conformity assessment then from what I understand it is performed for a family of devices. Is there a way to have the conformity assessment performed for our devices and separately for company B? We are the manufacturer of all devices and our devices are the same "family" as company B's devices.
Hope I'm making sense.
Thank you!
Our company produces and distributes medical devices under our name and we are also doing product development and production for another company (company B).
If we choose to go according to Annex IX for conformity assessment then from what I understand it is performed for a family of devices. Is there a way to have the conformity assessment performed for our devices and separately for company B? We are the manufacturer of all devices and our devices are the same "family" as company B's devices.
Hope I'm making sense.
Thank you!