I work for a contract medical device manufacturer that is FDA registered and ISO 13485 certified. Our customer is trying to get Canadian regulatory approval for his product we manufacture for him. As his company is the specification developer and distributor of the medical device, my understanding is that his company needs to comply with the MDSAP requirements. He believes we should be as the manufacturer of the device. Does anyone in the ASQ community have any experience or insight into this. Or possibly point me to some literature that could help clear this up for us? Any input would be appreciated.