Design verification is an essential step in the medical device development process. It gives quantitative data on whether or not the prototype of the device is working to specification. This allows for the understanding of problems that do not arise until the device is actually built. As you said, merzkrashed, doing it early allows for these problems to be identified and resolved early, thus reducing overall design time. If a company does not carry out proper design verification then it can lead to problems occurring whilst the product is on the market which will be highly damaging to the company and those affected by it.
I have some experience with this in my capstone class. We are using IR LEDs to illuminate the eye as a part of our project. We need proper design verification to make sure that these LEDs will not hurt the users of our products.
I think what mentioned on the thread theoretically is good to test each individual part of the project, But even though all the parts work allow does not mean when you put them together it will guarantee to work. Product verification is to compare input vs output and make sure it fulfills a customer need. SO you need to check it at the end as a whole system. I believe what mentioned is more toward risk management and how to ensure and minimize any mistakes along the way for the project, With coordination with the PM. However, you need to have a final product or a sample unit to run the verification on it.
As for Design Verification, I believe that a necessary practice is to let experts from a different discipline test the product under unusual circumstances. I think that there are circumstances that the product might be used under. While Verification is meant to ensure a product meets the operational needs of the user, it can also be widened to include unexpected conditions. Today, with the help of computerized simulations, experts can conduct a verification process with almost any testing conditions. However, this should only be a secondary process, not a main process in the verification experiment as most of the time users would use the product under normal conditions. Moreover, one must consider whether they need Validation or Verification. As "verification is proof that you designed the product correctly. Do your outputs meet your inputs? Have your inputs been written well and have you recorded sufficient outputs? The overall question is "did I design this device correctly? While Validation is subtly different. The overriding question is "did I design the right device?"(Ref. mddionline website). Also, an important question is what stage of verification or validation one might need? Prospective, Retrospective, Full-scale, Partial or Cross-validation/verification.
I definitely agree with the points listed above as to how to improve the Verification/Validation process. I believe the verification process is very important because it lets the engineers and other departments if anything is deficient with the product. Verification ensures if the creators are developing the product in the right way to assure it will be effective and functional. Validation ensures that the device meets all user needs and intended uses. This entire process assures each customer receives the most efficient product to meet their needs. This process can be improved by performing the V&V process a little earlier in the project development phases. I believe this would be a major improvement since it would let the company know during the design and development process of how the product is doing. This way the engineers can make changes to the product right then and there.
Design control designates the application of a formal methodology to the conduct of product development activities. Design verification confirming that the design output meets the design input requirements so we can detect if we design the device right or no?. Improving the probability that the device will reach an acceptable level of efficacy and safety.
Verification tells a company that the developed device meets the requirements for the product. This is done through tests and a lot of analysis, which are operations that cost companies money to perform. What makes it worth that money (besides the fact that you can't commercialize without it) is that a large part of the verification process is parts of the development process that should be completed anyway. Errors in the design can be detected early, before they affect the public and ultimately the company itself if anyone were to get hurt using their product. Since verification is a later step in the process, documentation should be ready for verification before the verification process starts so that it moves more smoothly.
Verification is very important as we need the design parameters to match with the proposed designs to avoid any faulty or any unavoidable damage. To make verification better i think the process should be very neat and strict without any exceptions, also the design inputs needs to be realistic so as to avoid damage by over expecting.
Verification is an important aspect of design controls that puts the claims and specifications defined by the project team to the test. In a general overview, verification helps assess a product meets both quality standards and performs as outlined prior to it being on the market. Furthermore, the tests in verification provide valuable feedback to the project team on whether the product is ready to enter the next stage towards completion or whether revisions still have to be made to it. Personally, as an NJIT student in his second semester of Capstone, I also have a demo coming up where our project will be assessed as we go through our created test plan. Aside from the project performing its primary function, our developed product will also be tested by the customer needs outlined at the start of our project by our adviser. For example, our product has to be lightweight, so we have to verify whether the weight we outlined in our specifications is met within the indicated tolerances. As for improving the verification process in design controls, I believe an important factor would be to have the tests conducted by not only more than one group, but also using different tools to check measurements. For example, dimensions should be measured by calipers or scales from different companies to ensure that the measurements are within the required tolerances for every test.
Verification is an important part of design controls since it ensures that the inputs match the outputs. It is a way to test the quality and consistency the products, making sure that all the design features of each tested sample are within spec. In order to improve verification, the verification department should keep in contact with the project team, detail their progress during design meetings, and confirm that the verification protocol and tests meet the standards of the FDA and project team. The testing timeline and deadline for the verification report should also be discussed and determined by the verification testers and other departments. The verification members should also communicate their needs as soon as possible to the appropriate groups. These needs include the number of samples required for testing, when the samples need to be prepared by, and required equipment. Each member should also undergo training on how to properly run the experiments and document the results. If time permits, the design team can also occasionally visit the testing lab to check on the verification process. These steps will help minimize tension due to obstacles caused by lack of communication or negligence in proper testing.
Verification is very important part of the project process, make sure you make verification accurate as possible. using verification we can check that a product, service meets requirement , can detect early mistake and fix it easy before it come complex. Make up a test for each input, Do the test and check the results, List all the tests in a document . Take all the tests results and show everything that passed .
Verification is important for a few reasons:
According to the FDA, “Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.”
So, Verification basically confirms whether the design outputs meet the design inputs. In order to achieve this, you need to define clearly what the design inputs are.
In order to have success in verification, you need to Ask yourself what your device needs to do and what it needs to go through to achieve its intended purpose, Define what conditions are best for your device and how those might change, Make these design inputs as clear, discrete, and actionable as possible, and Write design inputs that are testable.
https://www.greenlight.guru/blog/design-verification-and-design-validation
Verification is the process of ensuring that objective evidence is present and that the specific requirements are met. Any unforeseen side effects that it may have can also be recognized. This early detection reduces potential failure in the field, which could impact the health of the patient and even damage the reputation of the company. One way to have a good verification process is to make sure that every detail agrees with the design specification and to check the progress of every step of the way. Having a design verification plan would greatly improve the verification process.
Why do you think Verification is important ? and Your ideas to improve Verification process in a design control ?
Verification is an important process in the development of medical devices because it is the "check phase" as Dr. Simon calls it. The verification process checks that the inputs = the outputs, basically, each input must have an output to match and each output must be verified for the design to be successful. To verify something a test needs to be created. I think the verification process can always be improved upon by continuously modification the criteria that is needed to support purchase increase. This is why verification is so important.
According to 'Bonezone Article - Design Verification - Validation File', and FDA definition for Verification ' Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled'
So, Why do you think Verification is important ? and Your ideas to improve Verification process in a design control ?
For Example:
I think Good verification practice minimize commercial risks, risk to users and the cost of satisfying regulatory requirements. Also, poor verification practice can cause (for example) FDA recalls and user injuries and deaths.
Example to improve Verification:Do Early verification!, that will help you to learn about the properties of
the device and will help you to identify design problems early in the design process and therefore reduce rework.
Your thoughts ?
Hi MerzKrashed,
I completely agree that good verification practices can only benefit medical device companies and patients by a ensuring a device is safe and meets specific requirements. That being said, I don't think that official design verification should be done too early, or too often. This is because any official failures need to be recorded and reported to the FDA upon submission and too frequent/too soon of testing can leave a lot to be explained as more failures are likely. To circumvent this and still maintain that the devices are meeting the required specifications, I think that frequent testing should be done for Research purposes only to guide the efficacy and development of a product. This testing can provide feedback to the product development team who can use it to adjust and correct their products to meet these requirements if they fail originally. The benefit of this is that since it is only for research purposes, all failures do not need to be explained or reported however the team can get a good idea for when official verification testing needs to be done.
Does anyone share any similar thoughts or opinions?
Thanks,
Matt
Verification is very important when designing a medical device. It is necessary to show the compliance with regulations. Moreover, it ensures that fewer mistakes and better repeatability are going to occur. The customer is interested in knowing whether the product does what it’s intended to do. It’s better to catch the mistake of the product before it goes into market than having the customer catch the faults. I think the most crucial part in improving the verification process is to have everything organized neatly beforehand and document all values. The input should always have an output, and each input should have a specific test to check the results. Furthermore, there should be a criteria for passing the test to ensure that the specifications are being met.
