Design Control Documents

Answer:

For the design control document, we do have one available on hand: https://advisera.com/13485academy/documentation/procedure-for-design-and-development-iso-13485-2016/ .

Concerning the user requirements, you should think about the roles of each function in the company with respect to design and development. Some examples of inputs could be intended application, usability requirements, risk control and etc. For outputs, you should factor in raw materials, manufacturing processes and quality assurance.

For more information, please refer to:
-How to manage design and development o f medical devices according to ISO 13485:2016: https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/