Which element is NOT part of design validation requirements under QSR?

Design validation is a crucial aspect of the Quality System Regulation (QSR) for medical devices, focusing on ensuring that the product meets the needs of the user and is intended for the suitable applications. Each of the elements in the question plays a distinct role in the validation process.

Conformance to defined user needs and intended uses is vital; it assesses whether the design meets the requirements established during the design input phase. Testing of production units under actual use conditions ensures that the devices function safely and effectively in real-world scenarios. Software validation is also a critical element, particularly for devices that incorporate software to confirm that the software performs as intended.

Translation of device design into production specifications, on the other hand, pertains more to the manufacturing process rather than the validation requirements. While this step is essential for turning a design into a product, it does not directly relate to the validation of the device against user needs or intended use. Instead, it focuses on the operational aspects of creating the device, which falls outside the scope of design validation under QSR requirements.