Design controls is a broad term that describes several procedures and processes used throughout the design and manufacture of a product, the basic focus of which are to ensure the most effective product design and that what is produced consistently reflects that design and the product’s intended use. Design inputs, outputs, review, change controls, validation, verification, transfer and the design history file all constitute aspects of design controls.

As someone who has worked in the medical device field for a few years, I can say that having effective design controls in place can go a long way in preventing and bolstering the defense against products-liability claims alleging a design defect—one of three bases for products liability. The basic allegation behind a design-defect claim is that a safer design exists for the product in question, but that the manufacturer failed to use the safer design. Robust design controls help to ensure that the safest, technologically feasible, design for the product is being used. Further, in the event of litigation, design controls can be used by the manufacturer to demonstrate that the risks associated with alternative designs were weighed and considered.