The design must be verified and validated after all User Needs, design inputs, and design outputs have been generated. This is frequently referred to as "V&V." But what exactly does it mean? At this point, you'll need to establish: You created what you intended (Design Verification) and your design fulfills your requirements (Design Validation). Design Verification, in more specific terms, is in place to ensure that the design output can consistently meet the design input. In this case, objective evidence, such as test reports, is frequently required to confirm that the device can satisfy the design input. Design Validation, on the other hand, ensures that the final product meets all of the User Needs identified in the first stage.
To put it another way, design verification ensures that the product is correctly developed, whereas design verification ensures that the correct product is developed. Future articles will cover Design Verification and Design Validation in greater detail.
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.
