Design control is often a major source of confusion although; with time it has become more structured and better understood.
Design as a Function of Product Quality
The design process is really the foundation of product quality, and just like a building if the foundation isn’t of sound construction the entire structure is at risk, or in the case of design the entire product.
Application of Design Control
The design control process not only applies to medical device products, but also should be applied to manufacturing processes and equipment, and an analogous system is used for software systems as well.
The Waterfall Method
The waterfall method of design is depicted in the figure shown. The waterfall diagram is the classic simplified view of the design process as depicted in the FDA’s Design Control Guidance . The real design process is typically much more complicated as there are many elements which are being developed concurrently, but the waterfall diagram is a good basis for which to understand how the process is envisioned.