What is the main difference between design verification and design validation?
Hi aashutosh it's a good question to ask verification is something that you carry out to test weather your output meats your input requirement. Whereas your validation is where you check if your output meets user requirement. So for example in a current to voltage converter circuit verification would be if you put in 3 amp of current do you really get 6V output as specified in product specification. Where as validation is something in which you would check if user really needs 6v as output or if user needs can be resolved in voltage less than 6V output. So in a nut shell verification is you input something and check if thats what you are really looking for and validation is something in which you check if that's what user is also looking for.
I think @smithshah sums it up well above.
Design Verification Inputs=Outputs
Design Validation Outputs=user needs and intended use
Design Verification is- did you design the device correctly? Does your device meet the design requirements you set out in DID? Whereas Design Validation is-did you design the right device? Does this device satisfy the user needs and intended use?
Verification is mostly paper work. All the design inputs such as specifications, government and industry regulations, knowledge taken from previous designs, and any other information necessary for proper function are compared with the design outputs such as drawings, assembly instructions, test instructions, and electronic design files. The comparison must verify that each requirement in the inputs is accounted for in the outputs. Validation involves creating the product to prove the design, which is then thoroughly tested to validate that the product, as designed, will meet all the necessary requirements defined in the Design Inputs. This step usually entails more time and testing conducted on production models. To make sure that all requirements are fully met, all measurements and tests are done on the validation unit.
Design Verification is focused more on paperwork stage of the project preparation. I will include all design imputs: specification, industrial regulations, and any important information regard to project planning and live document such DID. And you compare it against your output such as drawing, design specification, special testing, etc. The obvious importance of this step is to make sure that the design has not missed addressing any requirements. However, Validation is when you have an actual build of the product and run test against requirements of verification. so, you can think about it as engineering model to approve the concept for mass production after passing the verification and validation testing.
Verification is a theoretical exercise designed to make sure that no requirements are missed in the design, whereas validation is a practical exercise that ensures that the product, as built, will function to meet the requirements.The purpose of Design Validation shall prove the medical device meets the User Needs and intended uses.
Design verification is important for ensuring the success of a medical device. It demonstrates that the product is safe ,designed correctly and design input meets design output. Design verification should start at an early stage when design input are developed. If process of proving that medical device is correctly designed starts at an early stage then Design output meets design input during the formal design verification. Design verification is an important part of regulatory submissions . Regulators needs the evidence that medical device is safe and satisfies all requirement. Spend more time in defining the design input so that design verification gets easier.
Design Validation is a Design Controls activity that happens late in the product development .This is the stage where you actually build a version of the product and validate against the user requirements. The process of validation generally occurs as one step or multiple steps of the process, usually in stages and is used to determine if the project is meeting specification.The specifications of the project are highly detailed, and the project manager will evaluate the validation process to be sure the project is meeting the requirements. The validation helps advance the project and measures progress.The key benefit of this process is that it brings objectivity to the acceptance process and increases the chance of final product, service, or result acceptance by validating each deliverable. Design validation provides evidence beyond theoretical that the device you designed is truly safe and effective within the context of those same design input requirements.
I think a good way to really tell verification from validation apart is to think as verification as the theory and validation as the practice. Verification of a device begins with the idea of a project. While validation happens once the project is already produced and it is time to test if it really works.
During my capstone senior design project, my advisor explained the difference between verification and validation as verification is performance testing to ensure design outputs meet the design inputs while validation is simulated use testing to ensure that the device created meets the needs of the user.
This may actually mislead people who read this. Design verification is an end goal where it is good to keep in mind to think about the verification testing needed for a product in the early stages, but the actual testing must be completed in the later phases of the design process.
Design verification and validation work simultaneously with one another as they use different lines of the trace matrix that is developed to list out all design inputs, outputs, and specifications needed. Both areas of the design process occur right before product launch as they need to utilize process equivalent parts. Many times, you can't verify a product unless the final design or drawing matches the final prototypes. Design verification heavily involves the use of quantitative data sets for packaging, sterilization, stability, and mechanical testing to satisfy design specifications. Design validation is a more qualitative set of data where a panel of customers can satisfy the design inputs by their answering of questions during a mechanical lab, meeting, or cadaveric lab to go through the motions and say whether the product works as intended and advertised.
The difference between Design verification and Design validation can sometimes be confusing. But the differences between them are significant as confusing as they may be.
Design verification determines if you’re building the product right. Are design outputs matching design inputs? Verification is testing that your product meets the specifications / requirements you have written.
Design validation tests how well you addressed the business needs that caused you to write those requirements. It is also sometimes called acceptance or business testing. Put simply, design validation determines if you are building the right product. This also includes using the device made in living people or cadaver.
Design Validation is testing method to make sure that the device matches the end user as intended including testing of production equivalent units under real-use conditions, so it just focuses on customers usage requirements. On the other hand, design verification is testing that the project design outputs meet the design inputs, including tests, inspections, and analyses. Test results of the design verification shows that the design outputs meet the design inputs by checking product requirements and design specifications
What is the main difference between verification and Validation? The answer lies in the fact that one is done before a machine or a design is out for production and the other one checks if the output will be favourable or not. In case of a machine verification the parts of the machine are working correctly is being checked. Similar to this is the design verification where the designs are analyzed and corrected. The design validation is done when the output of the design is favourable. A vaccine which is in the trials for covid, has a verification step and a validation step which the project management has to pass. The design verification goes first and subsequently the validation.
When creating a device, the team comes up with the product specifications and requirements which essentially tell you how the device does what it's supposed to do. These are your design inputs. Design verification entails tests or analyses that show you that your device meets these requirements and specifications. Design validation intends to show that your design specifications and requirements meet your customer's needs.
Design verification checks that the inputs are equal to the corresponding and correct outputs. Each input has an output and each output must be verified. This is typically a necessary step in the executing phase. Design validation checks that the inputs are equal to the needs of the user or the intended use. Each input needs to be validated and this step is not always necessary.
