Software management for medical devices

In the overall management of a software project, the Product Assurance activities encompass a wide variety of tasks throughout the project life cycle. These activities are accomplished through a combined application of configuration management (CM), verification and validation (V&V), test and evaluation (T&E), and quality assurance (QA). These activities usually begin during the feasibility and requirements phase of the project and carry through to the maintenance phase. They may be implemented in a variety of ways and in varying degrees, depending on the size of the company, the organizational structure of the company, the type of product manufactured, and other factors. This project researches, defines, and applies these Product Assurances management functions to the field of medical software. This particular field is felt to be more sensitive to software errors and omissions than other fields of commercial software since the software may be depended on for supporting or sustaining human life. The outgrowth of the project will be a set of Product Assurance management plans applicable to a large manufacturer of medical electronic products containing embedded software.