Design Control is Not Product Development

One common mistake is to think of design control as the product development process. While this is the core of design control, it’s much more effective to view the product as a lifecycle approach and realize that design control actually encompasses the entire lifecycle of the product.

Design Control Doesn’t Include Marketing or Feasibility Requirements

With that concept in mind, it’s important to note that the design control process does not encompass any marketing requirements, or any feasibility requirements. These phases are still critical to designing a marketable product, but aren’t covered by the regulations because the regulations aren’t concerned with the success of the business–only the safety and efficacy of the products that are put into the market place.

Design Input Requirements

It is important not to mix up the marketing requirements and feasibility studies with the design input requirements. These are also sometimes referred to as product concept documents.