Design controls are an integral part of the success of any product, from the quality, performance, safety, reliability, performance standards and physical characteristics. Design controls looks into the inputs, outputs, validation, verification, and design planning, if there exists any poor planning in lets say user needs (inputs) the output of the product could fail and not meet the needs of it’s customers. When looking deeper into design controls and viewing it in a larger spectrum, if lets say the design fails due to poor testing, it could potentially either harm patients, mal-diagnose, or even cause fatalities. These types of problems could cause companies to lose shareholders, go bankrupt for lawsuits and lose reputation, these types of problems could have been avoided if more attention to detail was applied to the design controls. the design controls created by the FDA and gold standard procedure in the US was created after the many years prior of medical devices creating products and hurting many of their customers, these regulations have intended purposes.