ABSTRACT
Software Quality Assurance has thus taken the form of directing and documenting the development process itself, including checks and balances. By documenting requirements in a simpler way, the development effort can be reduced by lowering the overall product development complexity. As medical products encompass more features and technology, they will grow in complexity and sophistication. The hardware and software for these products will be driven by necessity to become highly synergistic and intricate which will in turn dictate tightly coupled designs. Verification and validation must test the product to assure that the requirements have been met and that the specified design has been implemented. The product specification is the first step in the process of transforming product ideas into approved product development efforts. The product specification should be a controlled document, that is, subject to revision level control, so that any changes that arise are subjected to review and approval prior to implementation.
