Design verification and validation are the procedure to check during medical device development process that the product meets the specific requirements and error free. Design verification is testing that the design output meets the design input and requirements you have written. “Did you build what I said?” Design validation are intended to test how well you addressed the customer needs that caused you to write those requirements “Did you build a right thing?”
It is very important to know the difference between verification and validation plan while working in medical device company. It was also not clear to me in the beginning but once after working on a project during capstone, it became simpler to understand since we had to write these plans for our project. Basically, verification is matching all your outputs to the inputs of the product and validation is making sure the product does what customer has asked for. As an example, lets say customer would like to find deformation of something. That would be one of the customer needs. As design inputs you would use strain gauges and get the output. When you check if the strain gauges worked accurately or not, that’s verification. When you check if the product is giving out deformation, which would be validation.
I do have to agree with most of what you have said about design verification, we all know that design verification is pretty much to whatever it was written in the DID document it must be verified to make sure that it meets the input with the output, and to be able to do this each of the input that was in the DID document the engineer have to figure out a test that can prove the output that was written, if it different well it must be noted, or figure out if the test was done wrong and do the test again but also needs to be noted. When it comes to design validation, like Dr. Simon said in the lecture, it has to do with clinical trial, animal testing. This is the part where I have to disagree with you not only the nurse or the doctors are the one that do the design validation, also engineers who are working in the clinical trial can perform this test to be able to make sure that is valid.
Design verification deals with confirming the inputs of the project with its outputs. It is a way to see that the requirements have been met and that the device was created in its entirety. Validation confirms the function of the product in the intended application. For example, a car would be verified by checking if it had an engine, wheels, windows, etc. It would be validated by testing how it drives and moves people from one place to the next.
Most of the posts above explain the difference between verification and validation well. If there is still confusion on it, an example that I've found helpful is say you're designing a new tool for surgery. Based on discussion with a surgeon, you take the user needs they discussed and develop those into actual design inputs with detailed specifications. Once the product is developed and you have the design outputs, design verification is ensuring that the design outputs are equal to the design inputs, so you're making sure that it meets the specifications you determined. Design validation, however, is not about the design inputs, but it is to ensure that the product works how the user needs it to. If the design outputs were misinterpreted from the user needs, the product may meet all the design inputs that were determined but not actually do the job that it is needed for.
The main difference between verification and validation is the end user. Verification is more or less a premarket step that distinguishes between the design inputs and outputs. This looks to answer the question of how closely the current design matches the inputs specified by the company. Validation can be a premarket step but it is mainly a step that really takes shape after the device hits the market because it considers the opinions of the customer. This aims to answer the question of how closely the device is approved by the customer based on the initial input of the customer’s needs. Both steps require an approval based off an initial input, the difference is the source of input, either internal or external.
Design verification is a process that make sure the output is equal to the input ,It is confirmation by examination and provision of objective evidence that specified requirement have been fulfilled. Design validation ensure that user needs are met by the medical device. Design verification can occur during different phases of design development. Design validation should begin after design transfer to production specifications, Design validation can start as soon as user needs .
Verification and Validation are two different processes where validation follows verification. Verification is where you test/verify that the design outputs match your design inputs. It can include tests, analyses and inspections. Verification is typically making sure that you have objective evidence that specified requirements are met. While Validation is a testing process by which you prove/validate that the device you’ve built works for the end user as intended. Verification always comes first just as the way how ingredients and recipe come before preparing a meal and evaluating how the meal tastes would be validation.
Design verification and validation are main elements in design controls. Design verification is where the design inputs are verified with its output and all outputs must be verified. Whereas design validation is needed to check how well the device is designed for customer needs. It is basically the process checking for user needs.
Design verification is a required part of design controls regardless of the type of medical device, but the necessity for validation varies. Verification and validation both take outputs into account, but verification compares it with the inputs and validation compares it with the user needs. Validation can be skipped if the specs also encompass the user needs (and therefore already tested during verification), and if the device does not involve direct patient interaction and clinical trials. For example, a class III device that physicians are going to test on their patients will defintiely be undergoing validation.
While watching this week's lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs align with the design inputs. They both must also be documented in the Design History File (DHF). Why are these two sections separate though because they seem to share similar purposes. Hopefully someone can clarify this with more details. Thank you!
This is a very common question, as these terms are often used confused with each other. Design verification is ensuring all of the design outputs meet the design inputs, while design validation is ensuring all of the user needs have been met.
So, for example, if a design input is that a device needs to withstand X pounds of force prior to failure, verification testing would be done to test the limit at which the device fails. If the device fails above X pounds, the design output would point to the passing test results, and therefore, the design input is verified by the design output.
On the other hand, a user need may be that there should be no sharp corners on the device that could cut a surgeon's gloves in the O.R. To validate this, the design team would have a panel of surgeons and have them fill out a questionnaire for all of the user needs, and one of the questions would be something like "Do the parts have sufficiently rounded corners which would not cut a glove during surgery?" If the surgeons answer "Yes", then the user need has been met through the validation activity of surveying the surgeons.
Because of this flow in procedure, typically the design team will ensure all design verification activities have been completed prior to engaging any surgeons in design validation activities, because the design team will want to show the surgeons a nearly finalized product. Also, once the surgeons see the new product, they'll most likely want to be able to use it as soon as possible!
Design verification and validation are very similar, and I struggled to grasp why they needed to be separated into two distinct phases as well, when they seem be almost the same thing. What I have learned is that verification checks that design inputs = outputs. Whereas, validation checks to make sure that by satisfying these inputs, the original customer need is successfully satisfied. So in the initial phases of product development, customer needs are identified, and then turned into a list of inputs that the product needs to satisfy in the DID. After development, verification tests are performed to ensure that features of the product successfully meet these inputs. Additionally, Validation is done to ensure that original customer needs have also been fulfilled. So, it is in a way a double check system, but if one of these phases were not there, and after years of development, it turns out that inputs created in the DID actually did not satisfy the customer needs, it would be catastrophic. So for that reason both verification and validation are crucial parts of the development process.
Verification and Validation are indeed similar phases in the medical design development process but they are different in the sense that they function to prove different things about the product. The verification phase proves if the device outputs meet the device inputs and basically verifies if the product was made in the correct manner. However, validation proves if the customers needs are fully met when they receive this device. This phase validates if the correct product was made for the customers needs. Verification testing will mostly involve testing where all of the specifications of the device are put to trial. If there are any failures, then this is where there may be some design changes made to the device. Validation testing will more so involve the customer being at the testing to assure if this device is exactly what they need.
Design Verification and Design Validation are phases of Design Controls, which used to test the design and ensure that the medical device inputs are match the outputs and the user need. Some cases adequate with verification process and do not require the validation. Verification procedure is done to make sure that each input in the design input document must have an output, the output is equal to the input. Validation design is checking the medical device is meet the user demands.
While similar in many ways, Verification and Validation are used to check different components of a device. More specifically, verification checks that all inputs are equal to their corresponding outputs. This is done through making a test, doing that test, seeing the results (output) and comparing it to the desired output. Validation checks that each input is equal to the users needs or its intended use. This is done the same way that verification is done.
