Medical product design overview

The relationship between the main subsystems and other minor systems is illustrated schematically in Figure 12.4. This places management at the core of the quality system, with the other systems arranged as major and minor satellites that revolve around it. This perspective provides the basis for the Quality System Inspection Technique (QSIT), which the FDA uses for auditing medical device facilities. This is based on a top-down approach, which starts with management controls and then looks at three other key subsystems of Design Controls, Corrective and Preventative Actions (CAPA) and Production and Process Controls. The belief is that by focussing on just these four subsystems, you will actually touch on all the other subsystems and obtain a sufficiently satisfactory overview of the state of compliance of the facility. 

An example of a study specifications worksheet is shown in Figure 40.1. The first page of the worksheet, entitled Study Details, is designed to provide an overview of the study and includes information on key parameters, such as the number of patients, number of visits, expected enrollment rate, and number of sites. It also includes information on the health-care setting (e.g. academic medical center, private practice or managed care) and the regulatory status of the product. The Materials and Actions section of the worksheet is divided into 21... 

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