Design Control states that when manufacturers or suppliers develop a product subject to design controls, they shall establish and maintain the proper documentation to ensure the specified design requirements are met. It sets practices and procedures to assure that the device meets user needs, intended uses and specific requirements. Design control is about planning, design execution, testing against specifications and requirements, and uncovering and fixing problems at an early stage. It guarantees that the product will meet the regulation requirements through the following key elements: design & development planning, design input, design output, design review, verification, validation, transfer, design changes and design history file.