A good product retains its original/intended use and provides the desired results. In order to check if the design of the product during the course of its development is delivering the desired outcome at every stage without compromising the end result, verification is required.

Verification helps to keep in check the timelines and the quality of the design in check and prevent any deviations that might have occurred along the way thereby reducing time and effort invested in delivering the desired product outcome.

Verification is typically making sure that you have objective evidence that specified requirements are met. It is usually done by tests, inspections, and in some cases analysis as well. The companies want effective, relevant, and well-documented verification activity that is compliant with medical-device regulations. Medical devices come in many different technologies, shapes, sizes, levels of complexity, etc. Verification activity is typically driven by the regulatory environment and international standards.

I think the best way to improve is to do verification early. To solve the problem if possible.

Verification ensures that the the customer specifications are meant. Without verifying specifications, you are blindly trusting what the manufacturing department took to be what was meant on the DID. In industry, this is a dangerous assumption because the departments rarely if ever understand each other fully. If a product is not verified, the customer can come back to the company and refuse to pay for the product because it is not what they asked for. Now the company has lost the resources, time, and money that the product took to make. In addition, the customer will most likely not deal with the company again and spread a negative reputation. Verification of inputs is needed as a safeguard against waste. Not verifying data leads to wasted opportunity, money, and future opportunities.

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.

I agree with my classmates and what they mentioned above that An effective product is the fruit of good design controls and other properly implemented steps. Also, it's important because in the initial stages of design verification is a key quality assurance technique. As the design effort progresses, verification activities become progressively more comprehensive. In order to check if the design of the product during the course of its development is delivering the desired outcome at every stage without compromising the end result, verification is required. As mentioned early verification testing; start testing design on simulator before the official completion of a physical system.

Verification is one of the most important steps in the design control, that it not only can address the questions of whether this is effective enough to do what potential customers want it to be, but also confirms that to what extent of adverse environment can this medical device functionally work, and will it have safety check to avoid injury to people.
My suggestion for improving the verification step is to develop a verification team that always go through and check on every steps within the project, this will make sure that every possible illegal operations, unrealistic inputs, and other design issues will be discovered as soon as possible.

Verification is a proof that the designed product is correct. Design verification demonstrates that the medical device design output meets the design input. Verification is all the inspection, measurement, analysis and testing that one has the correct output specification relative to the design input requirements. Verification is less about testing and more about ensuring that as one moves from the initial design input requirements and subsequently translate them to more refined requirements to final design output specifications. Testing if the part of the design verification other methods such as inspection and analysis are acceptable too. Verification ensures that each element of a device meets the appropriate specification and standard. Verification always comes first just like building materials. It ensures the quality assurance of the device. Verification can be improved by using appropriate tools in medical device software development.

As mentioned above, verification is one of the most integral parts of the design control process and probably where engineers encounter the most problems. This is the first step where you really get to see if your prototype is on the right track towards becoming a successful product according to your customer needs. These customer needs are the inputs for the product and define all of the functional requirements which need to be included. If you do not meet your customer needs, then essentially there is no customer and no market to sell your product. Each input requirement will have a corresponding output feature which was included in the design to fulfill that need. Various test methods need to be employed to do this verification check and determine whether or not some changes need to be made to the design. I think one problem with verification is the leniency in which a company may accept a certain output as satisfying its original requirement. If you want to check the color of a part you could do a visual inspection and determine it is red. You could also use a spectrophotometer and obtain the exact color values. Both test methods will determine the part is red and thus a successful design feature but one is inherently more accurate in determining compliance. So engineers need to decide which tests are qualified to determine success.

Verification is one of the most critical parts of the design process. It is the stage proving (or verifying) that all the work that has been conducted has been successful. It shows that the product actually meets the design specifications that were created at the start of the project. A good verification process ensures that the product hits the specs with high confidence. It is also, in my opinion, the last stage where changes can be made without it being too late. No one should ever strive for this though, and good legwork should be done to ensure that this doesn't happen. If a product fails verification, this can be a test or a product issue. If it is a test issue, the test simply needs to be redesigned or debugged. It's still a lot of work but won't necessarily take a lot of time and resources. Now if it is a product issue, the design of the product may need to be revised which will require a lot of hands and deadlines may need to be pushed but the change is still possible without basically starting over.

Good verification involves ensuring that the test to verify the design is repeatable. A single instance of a test may pass but then the next might not. So including a operating procedure to define a gauge r&r on the test and system would be my suggestion for a good verification process. From my experience, many larger medical device companies already practice this.

Verification is making sure what you say is going to happen actually happens .. If you say a product is supposed to do something and it does not do it, you'll end up getting sued and, even worse, could hurt someone. For a good verification process, you should make sure the results are repeatable over a large number of trials.

I believe verification is important because it makes sure that the device you are creating is exactly as you intended it to be, so that there are no unanticipated problems that may occur later on. By verifying that the device works and is safe, it ensures that it will later be successful on the market. This also keeps the patient safe from failures in the device. Also, by testing your product early on you are saving the company time and money by not hindering the design and transfer process. An improvement would be to do have the verification process happen as soon as possible. That way if there is a problem and a change request needs to be made, it will be easier and quicker to handle. The more time that goes by the more back tracking you will have to do and the changes will be harder to make. Some more improvements would be to spend more time on the planning phase for the verification test. This will ensure that you are effectively testing for all specs in the model, that the test are run smoothly and at a quick pace, and that testing and results can be quickly put into a verification document to receive approval.

All of the design meetings held throughout the design and development stages were to ensure that the product design inputs met the product design outputs. This means that your final product functions in the way that it was intended to and meets the customer needs. Design verification and validation falls under the design output category of design controls. Most of the product recalls carried out by the FDA results from poor design controls and failed verifications, which goes to prove that all of these components are very important in product development. One way to further improve verification at the end could be to hold more frequent meetings and make sure everyone on the team is on the same page.

Like many of you have said, verification is key to a successful device that will benefit the end users. However, carrying through with this process is imperative to the success and potential risks a company is taking when producing a device. Like Dr. Simon had mentioned, if verification is not done properly, it could lead to issues with the FDA.

The earlier this process is done, the better. Verification checks to see if the prototype does what it was designed to do. If not, then the company is not fulfilling the requirements set by the customer. Ensuring that the device meets the input and outputs through reviewing the DID acts like a once over before sending it out for production.

One thing that can improve the efficiency of this process is coming up with a verification protocol early on in the developmental processes. Once all the primary design documents are completed and testing has commenced, one can get carried away with the developmental process of the device and lose track of the initial inputs and outputs put in. Therefore, I propose that a verification protocol should be made up as soon as possible with all the inputs and outputs set out preventing any set-backs that would delay the release of the device.

I agree with the verification points mentioned above as well. Verification process makes an emphasis on attention to detail, to avoid major mistakes. Early verification can be helpful to study the product as well as ensuring all points are in order. In case something is erratic or missing, early verification will allow improving the device or product. In design control, the verification process has become essential, because it allows the team to be productive, efficient and improves a great amount of attention to detail so that the product/device can meet the specifications on point.

I believe that the design verification is important because in the initial stages of design verification is a key quality assurance technique. As the designprogresses, verification activities become progressively more comprehensive. Beside that we need to varify that the device works and is safe, it ensures that it will later be successful on the market. Design verification is an important part of regulatory submissions . Regulators needs the evidence that medical device is safe and satisfies all requirement. This also keeps the patient safe from failures in the device.