ABSTRACT
A product development process ensures that the design, development, and transfer of a new or modified medical device will result in a product that is safe, effective, and meets user needs and intended use requirements. As shown in Figure 6.1, design controls begin with the approval of product requirements. Product requirements include the needs of the users and patients and intended use of the device. A design and development plan is developed to describe the design and development activities. The product requirements are converted into technical design inputs (System Requirements Specification) that serve as a basis for the design of a medical device. Iterations of the design process result in design outputs that are verified against the design inputs to ensure that the design outputs adequately address the technical design inputs. The finished device is validated to ensure that all product requirements have been addressed. Final product and process specifications are transferred to production. In the course of the design process, documentation pertaining to the design of the finished device is maintained in a design history file (DHF). Changes to the device design are managed and controlled both prior to and after design transfer until retirement. Risk management is performed simultaneously with device design and development. Formal design reviews are conducted at appropriate points to evaluate the adequacy of the design to fulfill all requirements.
The product concept must be documented. This can range from a brief description for products similar to existing ones to a formal document, such as a marketing requirements document, for new and complex products.
