In a broader term, product development and design controls are very similar. Product development is about developing a product while design control is about ensuring to develop the “right” product. Apparently, one can say that Design Controls are a part of a broad product development process. The product development process includes developing some prototypes, test planning, feedback mechanism, etc. It aims to reach the launch phase of the medical device. On the other hand, design controls are all about ensuring the safety of the medical device, making sure that a medical device meets the defined requirements; the user needs and the product’s intended use, and manufacturability of the designed and developed device.
