I think Design Validation is the most important aspect to Design Controls. Design validation checks that the inputs equates the user needs or intended use. Without validation, the device is defeats the purpose of Design Controls. Validation is necessary to ensure that good product is on the market, the product doesn't hurt people, and ethical. These measures can not be assured without a testing before release. A mandated Design Validation is require human involved clinical trials. When human are involved, it is important to ensure that the design controls are safe, effective and compliant with the FDA.

it is widely agreed and I agree that the most important aspect of Design Controls in the medical device development process is the documentation of each stage of the design process, as well as the verification and validation of the device design. This documentation ensures that the device is developed in a systematic and controlled manner, reducing the risk of errors or defects. Verification and validation processes, such as testing and clinical trials, are critical in ensuring that the device performs as intended and meets the needs of patients and healthcare providers. The documentation and validation of design controls help to ensure that the device is safe, effective, and meets regulatory requirements.