To have an adequate Design Control System – one that will pass audits at the minimum, you must have Design Inputs, Design Outputs, Verification, Validation, Design Transfers, Risk Analysis, the DHF.

For Design Input this includes physical appearance of the device, labeling and packaging, maintenance, functionality, safety. Essentially it is the physical and performance characteristics of the device.
The Design Outputs are the results of the total design effort. It consist of definable and acceptable criteria and conformance to whatever the design inputs were
The Verification is evidence and confirmation that the design output meets the design input. Evidence for this includes engineering test and reports.
The Validation is evidence and confirmation that the design specifications of the device meets the user needs and intended uses. Evidence for this includes batch records, lots, first production runs.
Design Transfer are creating the procedures to ensure that the designs are put into production correctly and are maintained.
Risk analysis is documenting and recording any potential hazards, errors, calculated risk under certain conditions, risk acceptability, and identifying changes to reduce identified risk and mitigate new hazards.
DHF is for tracking the design history of a finished device and includes all references and information that was used to design the device from start to finish.

FDA audits will want to look into these type of records therefore it is imperative to establish and track all the constant updating of these documents.