Regulatory Affairs Certification (RAC) Practice Exam

Which element is NOT included as a requirement under device design validation according to the QSR?

1. Testing of production units under actual or potential conditions

2. Conformance to defined user needs and intended use

3. Software validation

4. Translation of device design into production specifications

The correct answer is: Translation of device design into production specifications

The element that is not included as a requirement under device design validation according to the Quality System Regulation (QSR) is the translation of device design into production specifications. Design validation primarily focuses on ensuring that the device meets defined user needs and intended uses, which involves testing the device under actual or simulated conditions to validate performance. This includes evaluating products through both pre-production testing and conforming to specified requirements, such as user needs and the device's intended use. Software validation is also a crucial part of device design validation, particularly for devices incorporating software components. This practice confirms that software performance aligns with predetermined specifications and addresses user requirements. Translating device design into production specifications, while important for manufacturing and ensuring product quality, falls more under design transfer or the subsequent stages of product development rather than design validation itself. Thus, it does not meet the criteria of design validation under the QSR.