1.3 The processes required by this Schedule, which are applicable to the medical device and in-vitro diagnostic medical device, but which are not performed by the manufacturer are the responsibility of the manufacturer and are accounted for in the manufacturer's quality management system. 1.4 If a manufacturer engages in only some operations subject to the requirements of this Part, and not in oth ...

7.4.3 Verification of purchased product: The manufacturer shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the manufacturer intends to perform verification at the supplier's premises, the manufacturer shall state the intended verification arrangements and method of product release in the purc ...