Once the design phase of a product is completed, a production phase should start. The transition of these phases must be post a transfer plan and transfer report to conclude the completed phase. The design transfer plan documents the process and the activities which are needed to transfer the device/part from the design phase into the manufacturing/production phase. The design transfer report documents the activities and the processes that has been used in the plan, to report any failures and to state whether the acceptance criteria have been met. In addition to, the design transfer plan and report have been bound together within a matrix that include all the potential transferred activities.
Our templates are developed with consultants who have over 20 years’ experience in the Medical Device industry and documentation that has been through successful audits.