ISO 13485:2016 Procedure - Design and Development - describe the process for controlling the design and development of product or services. We handle this procedure by outlining the responsibilities and the records that drive each segment of the design and development process. Clearly identify what inputs are required or suggested, what outputs may be, and so on. Specify who is responsible for the various steps in the process. The responsibilities may be different for different projects, if this is the case then identify them in the design plan.