Customer complaint—Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a medical device and in vitro diagnostic medical devices that has been placed on the market. 3.5 Implantable medical device—Medical device intended: (a) to be totally or partially introduced into the human or animal body or a natural orifice; or (b) to replace an epithelial surface or the surface of the eye, by surgical intervention, and which is intended to remain after the procedure for at least thirty days, and which can only be removed by medical or surgical intervention. 3.6 Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. 3.7 Design input means the physical and performance requirements of a device that are used as a basis for device design. 3.8 Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record. 3.9 Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.