Design controls are to demonstrate that a product completes the user needs, meets inputs and requirements, is proven to meet the standards, and meets the performance criteria.
The FDA clauses for Design Controls and ISO 13485:2016 clauses regarding Design & Development are almost identical. Each require that your design controls consist of design planning, inputs, outputs, design review, design verifications, design validation, design transfer, design changes, and design history file. It is very important to establish and maintain traceability through out the project. Done correctly, traceability will show the relationship and linkages between all of the design controls listed above.