As well as the ISO 9001 Standard, The ISO 13485 requires defining inputs required to execute the development. The inputs should be determined according to the design and the development activities.
Within the design and the development inputs requirements, the organization must refer to the next issues:

The ISO 13485 Standard requires defining which outputs are expected at the end of any development stage. The outputs must be supplied in a manner that would enable to verify them against the requirements of the design and development inputs.ISO 9001

At suitable stages of the design and the development, the organization must review it. The review must be systematic and defined. The review must also be a part of the design and the development plan.  While reviewing the development, the organization must refer to the next issues:

When changes occur throughout the design and the development processes, the organization is required to control them. The changes shall be evaluated whether they affected any aspect of the product and already delivered products.