I believe that verification of the product comes first and is followed by validation. Verification I would think happens towards the middle or after the midpoint of the project development and is followed by validation. A semi-final design is needed and has to be made in order for verification of that design and validation of that design to occur.If that design fails then the requirements have to be changed and verification and validation occur again until the final design passes.
I first want to emphasize what the difference between verification and validation is. Verification is intended to check if the product meets the design specifications. Validation is intended to ensure that the product meets the operational needs of the user. I believe that these two steps should occur multiple times in the product's timeline. For example, in the development phase of the product, verification occurs through a series of tests and analysis on the product that will show if it meets spec. In the development phase also, validation procedures may involve modeling or simulations that predict gaps or faults that might lead to a faulty product. In the post development phase, there's also testing for verification and validation. For example, for verification, there's repeated tests that are made to ensure that the product meets the original requirements. Post development validation includes modifications done to the product to ensure safety and usability by costumer.
Verification should be considered continuously during the design process, especially since successful verification often takes more than one attempt. It includes designing the set of experiments to physically test the product, and making sure the output matches the input(ex: in spec). Validation can only come after verification (if validation is required), since it can involve clinical trials(after the risk of failure is lowered through the physical testing during verification).
The most appropriate time to conduct design verification is once all of the design inputs have been specified within the document known as the verification protocol. This requires one to know their product's shape, function, dimensions, specifications and FDA/governmental regulations that a product may face and finding the appropriate methods for testing each of these specs ahead of time. This is done to ensure that a product will turn out the way it was intended. Therefore the best time to carry out verification is when all of these factors have been accounted for (assuming your inputs are flawless). As learned in lecture; the verification report must also be prepared to address any failed test results so that the validation can be facilitated.
The ideal time to carry out design validation is when a clinical testing protocol has been formulated (or simpler testing methods assuming a low-risk device). This is an important stage that must be properly timed since it ascertains whether the product is compatible with the user or not. This phase should not be rushed by any means since making any changes at this point may have a more costly outcome since validation is one of the later stages of the design process. If one is lucky with a low-risk device, then there may not be a need for validation at all.
One of the most important factors required for both design verification and validation is to have foreknowledge of how big the sample size will be for all testings to be done. Too few samples can lead to skewed/inaccurate data while too many samples may waste resources. How do sample groups differ between verification and validation? What other similarities do verification and validation share? These two processes often get confused, what could possibly go wrong if for example, clinical trials are carried out during the verification step for the design of a pacemaker?
Validation and verification should take place from the early to the final stages of our product lifecycle and even after the release of the final solution. The most commonly used methods are surveys/questionnaires, usability tests, card sorting, eye-tracking and a continuous monitoring of how users are responding and interacting with your product even after every release.
Verification and validation have an association but with some important differences.It is important to look into Verification and Validation in the early stages of design which is when developing required specifications for the product. Design Verification is a process that checks if the output conforms with the input and verification is conducted at all levels of medical device design. Validation however makes sure that the user needs and intended uses are met. Validation follows verification and is possible only after the finalized design and the device is built.
Design Verification and Validation should, on some level, be implemented throughout the entire life cycle of a medical device. You should verify that you can make each component of the device consistently within tolerance. You should also validate that you are including aspects in the device that the customer, or intended user, wants/needs.
I feel like the point that verification/validation will not always pass needs to be brought up more. Companies need to keep in mind that the verification and validation steps will not pass, so that if they fail the timeline is not drastically affected. Failing either can set a project back months if not longer. As to the specific when should either start it's hard to say. Some need to start at the beginning, other needs to start after the project gets of it's feet. However, it is probable that the sooner these steps are started the better the chance of the project succeeding and doing so on time.
I agree with the group that believes validation and verification should be enforce through out the medical design process. During the design process there are documentation and test studies which project manager must hold meeting where all departments must be aware on what each department's task are, they must go over all plans and result before confirming. Validation and verification are important because they help the group analysis and make sure that the medical device is on check with the customer needs, safety, and effectiveness for the public.
Verification and validation process covers all phases of product development and different many technologies. I think it is extremely important to consider this process early in the design stage when developing the requirement specifications for the product or the medical device. Another advantage of starting the verification and validation process early is reducing the cost if previously tested materials or coatings were used for the product. Clarity, conciseness, measurability, appropriate tolerances, accuracy, and testability can all impact the final design and overall manufacturability. (1) These specifications also provide the acceptance criteria for validation and verification activities.
The best time to do to do validation and verification is most naturally towards the end of a project/process. At this point, the roles and responsibilities of these tasks have been determined, meaning who will do what in what place in what capacity. More than that though, the determinations for what processes, verifications, and validations are needed have been made. This is highly important in managing the lifecycle of a product, especially in implementing small changes in response to management or regulation standards. In the design change process, determinations are made as to what validations and verifications are needed in order to implement a change. It would not make sense to perform these before the determination was made as it would create unneeded effort (validation done on aspects of device that were not even changed). For example, if a MD manufacutre wanted to add packaging sealant on the box of a MD (counts as a design change) there would be no point in doing a design verification on the MD itself as it is not changing. As such, a packaging verification/study would need to be done so as to see the impact of the changed packaging.
Validation should take place from the early to the final stage of our product lifecycle and even after the release to the final solution. Verification and Validation are independent procedures that are used together for checking the project. Verification is the process of evaluating the intermediary work product development lifecycle to check if the project are in the right track of creating the final product. Validation is the process if evaluating the final product to check that the project meets the business and customer needs.
The best time for validation and verification is when all the deliverables and specifications of the project are figured out and then it’s time to manufacture and test out the actual product. You must make sure that the product looks like what it’s supposed too and make sure it works the way it’s supposed too. To do that, those items have to be figured out before designing the project. The scope should also be figured out first to see what the product is used for, that way you can validate it. You have to make sure that it works effectively because then there can be risk in the use of the product which is also found during validation and verification. These two steps are more towards the middle/end of the project cycle, dependent on if you have to fix any failures that occur when validating or verifying the project. Once all changes are made to make sure the validation and verification passes, the project cycle starts to reach the closing phase of the cycle.
Verification and validation are alike, yet different in what their purpose proves. Like mb698 said, validation is to make sure the user needs are consistently met according to medical benefits. Verification is to make sure there is evidence that all requirements are met accordingly. Validation is mainly done during clinical trials and verification is done when the product is manufactured. It is important to take into account when to do validation and verification during the process.
The process of validation and verification is very important in device development. with that being said, when is the best time to carry out these two important steps during the project's span ?
Design control places Verification and validation at steps 5 and 6 in the project life cycle.
Verification is the act of comparing design inputs to design outputs to assess if they match.
Design outputs is the realization of the project initiative. Although its possible to have design outputs as mere detailed design specification, many time the actually design outputs come as a result of iterative implementation. So verification would come at the end of implementation
Likewise validation which is the validating of desired efficacy of the deliverable claims that are intended y the project. So again this would come at the end of implementation
