When design validation activities are being performed by a manufacturer, which element is NOT included as a requirement under device design validation section of the QSR?

In the context of the Quality System Regulation (QSR) requirements for device design validation, it is essential to understand what constitutes the validation process. Design validation primarily focuses on ensuring that the device meets the user needs and intended uses, as well as verifying that the design outputs translate appropriately to meet the defined requirements.

The aspect of translating device design into production specifications, while crucial to the overall design process, is not specifically categorized under design validation in the QSR framework. Instead, it is part of the engineering and manufacturing processes that occur after design validation has confirmed the device’s performance against user needs. This step ensures that the design is practicable for production but does not specifically validate whether the device meets the required performance criteria in its intended environment.

The other options correctly represent aspects of design validation as outlined in the QSR. Conformance to defined user needs and intended uses outlines the expectations for how the device should function in a real-world context. Testing under actual or simulated use conditions provides empirical evidence to support that the device performs as intended. Software validation is also considered critical, especially for devices where software significantly influences functionality, ensuring that the software works correctly and safely within the device.

Thus, while all these elements are integral to the product development cycle,