As we see it both the steps are done as the project approaches the closing stage. This is the final few steps that helps in assessing the result of the project which is going to end. I feel the verification must be done at the conclusion of the design. The verification is a process that helps in checking the specification and its characteristic features. The process which checks the technical needs are satisfied or not. So at the end of the technical process the verification can be done. It is the checking of design control and its stability over the time.
As in case of validation, this step predicts about the failure or success of the developed project. So this is a done at the closure of project. This is implemented as a trial before the product/project is actually applied into the field.

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 is intended to test how well you addressed the customer needs that caused you to write those requirements “Did you build a right thing?” I believe the right time to do design verification is at the end of each life cycle phase to be correct, complete, and consistent results. When the device reaches at this stage where its hardware or software prototype is fully functional; FDA requires medical device manufacturers to perform design verification and design validation processes to ensure that the finished product is safe and effective for its intended purpose.

I agree with the two above posts which state that he process and design verifications are done towards the end of the specified project.A successful validation program depends upon information and knowledge from product and process development. I would like to further emphasize that process validation encompasses a series of activities taking place over the lifecycle of the product and process. This can be broken up into 3 distinct ‘stages’:

Stage 1 – Process Design: The commercial manufacturing process is outlined within this stage based on knowledge gained through research and development along with the process of scaling up production of the product.
Stage 2 – Process Qualification: Encompassed within this stage, the process design is investigated to determine if the proposed process is capable of reproducible commercial manufacturing within the given tolerances.
Stage 3 – Continued Process Verification: Ongoing assurance is done during the routine production of the product that the process remains in a state of control. This to ensure the product remains within tolerances while being routinely manufactured and to observe any early warning signs.

http://www.fda.gov/downloads/Drugs/Guidances/UCM070336.pdf

I disagree with the posts above. The verification and validation covers all phases of the product development cycle. Its really critical to start the verification and validation at the beginning to establish the user needs and product specification. During the product development, verification is done to see if the product design input satisfies the product design output. Process verification is also completed to establish If the process input matches the process output. Finally during the end stages of the project, validation is done to conclude that the end product meets the user's requirements.

I agree with the comments above validation and verification should be approached at the close stage of the project. The idea is that you want to ensure that it meets the user needs through validation and you look at the design inputs/outputs through verification. I slightly disagree with one of the comments above, Quality Assurance from my experience routinely inspect the product to reassure the product is manufactured to its set standard overall it ensures that the device is compliant, While verification deals more with the product design and the building of the right system for the device.

Chris

I believe that the validation and verification steps are done throughout the process. The 9 design controls are ideal and the general layout of how a project should go. Unfortunately, sometimes after testing, unforeseen problems are discovered. Verification and validation is the first time you are actually testing this idea and in validation testing, one might realize that the user inputs in practice, contradict an input specification. One will submit a change request and appear to be at that step but in reality you are going back to the input stage.

I concur with the remarks above approval and check ought to be drawn closer at the nearby phase of the venture. The thought is that you need to guarantee that it meets the client needs through approval and you take a gander at the outline inputs/yields through confirmation. I marginally can't help contradicting one of the remarks above, Quality Assurance from my experience routinely review the item to console the item is made to its set standard general it guarantees that the gadget is agreeable, While confirmation bargains more with the item plan and the working of the correct framework for the gadget.

I think that there should always be quality testing throughout the project and not just at the end. Each component must be tested and inspected before they are assembled. This is important so that problems within the design can be easily identified and the problem can be pin-pointed without the dismantling the whole design. If there is something wrong with one design, it is also important to change the design as early as possible in order to avoid problems down the road.

The validation and verification steps are extremely important and encompass the overall design control process. Verification ensures that the design outputs adhere to the requirements given in the design input and is constantly conducted until they do. Validation comes at the end of the process when the device or prototype is produced to ensure the user needs are met. This also can go through various cycles of review and alteration until the project passes verification and validation.

-Romany

Verification and Validation should be done in accordance with Design Controls to ensure proper alignment with correct processes. Verification should be completed after outputs of a design have been established. Then as the device is being reviewed, validation should be conducted as well. I currently am part of the remediation team so I run validations on test methods to ensure that the process for each component/subassembly/assembly of the product is within specifications.

According to me, verification is about making something correctly whereas validation is about building a right product that sustains in the market for a longer period of time. The verification process is all about checking at regular interval if the designing/making of the product is being done properly or not with proper documentation of all the requirements needed for the product to be designed. whereas validation is done after the product is launched to the market. It is done by checking if it meets or fulfills the customer's satisfaction or not.

What I think is a product may pass the verification process, but it may or may not pass the validation process.

Let's take an example of a Medical device company. The company makes a proper MRI machine and that passes all the design criteria and has been produced with a well-defined manufacturing process which means that it has passed the verification process and it was launched successfully into the market. But it couldn't be that successful in the market because it was not that user-friendly or cost-efficient. So it can't be validated.

Verification and validation are distinct, but related activities that combined demonstrate through objective evidence that the medical device meets the design requirements defined and the medical device meets user needs and intended use. Before talking about timing of V&V, it is important to differentiate between PROCESS validation and DESIGN validation.
Per FDA, process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. While Design Validation is the establishment by objective evidence that specifications (specified requirements) conform with user needs and intended use(s). Typically, based on my experience, some process validation will occur followed by design verification. Then depending whether there is scale-up required, process that will be leveraged for commercial will also go through process validation. The design validation is typically the last part of these three activities. Depending on the strategy of the company, samples from small scale or large scale production can be used for design validation, but they must be representative of the image that will be marketed, otherwise the regulatory agencies may require some kind of bridging study. In terms of timing, typically process validation can occur around 2/4 of the project while design verification will occur around ¾ and final stage of the project.

In my opinion, the best time to carry out verification and validation steps would be consistently, as progress is made in the project. For example, on my capstone project, we are currently testing materials and designs as we develop in order to limit the amount of backtracking and re-developing we have to do when we find a failure. Verification and Validation are parts of the development process in order to display tests done on the device, their results, and what was done differently after knowing that. This is important for both the team working on the device development, and for the FDA. Leaving these steps until late in the process could lead to a major failure causing a huge step backwards in the process. Working to test, verify, and validate every step made in the process as you go, could be more efficient. Can development teams operate like this in industry?

Validation is making sure that the user needs are met that consistently provides the intended medical benefits. Design validation checks if the input is equal to the user needs or the intended uses. Design verification proves that the medical device meets the user needs and intended use. Verification is to make sure that there is an objective evidence that specified requirements are met. Verification checks that if the input is equal to the output. I think design validation may not always needed since verification is enough since Verification is fine and there is no need to make any changes then validation is not required. Validation is meeting the needs of the device.