I completely agree with the points mentioned above. An effective product is the fruit of good design controls and other properly implemented steps. Just as every ingredient is important, a good verification process ensures that a product will work based on its original design. It is also implemented to see whether there are other effects of the design or flaws and problems. This ensures that the bulk product that will be released for consumer use will not hurt them. This also reduces the possibility of additional cost which can stem from regulatory costs and litigation. Verification allows for scientists to see if their product performs as intended and also, any unforeseen side effects that it may have. 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 every step of the way.

Adding to what myton said above, the process of verification also is generally an internal check to make sure the product follows its initial design specification. A good product will stay true to these original regulations, specifications, and regulations that were originally mandated in the development phase. In addition, the verification process could also be performed in development, scale-up, and production phases.

As mentioned above, the main way to keep the verification process efficient and relatively painless to the company is to preform it early and often throughout the phases of the product life cycle. If a deviation from the original design specification is caught early in the life cycle of the product, both the monetary and time cost the company will incur to fix the issue will be minimized. In this way, a good verification process will help ensure critical timelines are met and that the overall progress of the product doesn’t fall behind schedule or over budget.

Adding to the previous posts, the format of the Design Verification is equally important. Although, format of the DV is not as important as the quality of information it contains. However, if the data does not flow correctly in the document then the readability diminishes. Having a standard format promotes better communication between the engineering teams and business units and reduces errors in the document. In addition, a well-organized, concise test plan and report is useful during quality investigations and serves as a historical document for future projects.

Just to add to what was mentioned by several people, they mentioned doing design verification early and often. However, design verification cannot be performed until the design is frozen, which does not happen early in a project. However, you can do characterization at any time throughout the design process to assess the design to make sure you are on the right track, and I would highly recommend doing this. I think one thing that could characterize a "poor verification practice" is having design inputs that are not realistic, and that do not challenge the device. Defining accurate, robust design inputs is absolutely critical to ensure the device will be safe to patients. A device that passed verification testing with flying colors does not necessarily mean it is a safe product, because it all depends on what the acceptance criteria was.

I think design verification is 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. Verification is a theoretical exercise designed to make sure that no requirements are missed in the design. For some technologies, verification methods may be highly standardized. In other cases, the manufacturer may choose from a variety of applicable methods. In a few cases, the manufacturer must be creative in devising ways to verify a particular aspect of a design. Some manufacturers erroneously equate production testing with verification. Whereas verification testing establishes conformance of design output with design input, the aim of production testing is to determine whether the unit under test has been correctly manufactured. In other words, production testing is designed to efficiently screen out manufacturing process errors and perhaps also to detect infant mortality failures. Typically, a small subset of functional and performance tests accomplish this objective with a high degree of accuracy. Therefore, production testing is rarely, if ever, comprehensive enough to verify the design. The purpose of Design Verification is to confirm your Design Outputs meet your Design Inputs. This is why you have to think about Design Verification when defining Design Inputs.
There is continuous innovations as every company looks for better and efficient ways to improve efficiency and productivity in Verification. This is the only way an increasingly complex design can be successfully taped out in a market driven schedule. Companies can also develop a software solution to improve this design verification.

I agree with comments above that verification is important to ensure that all specifications originally laid out in the inputs are implemented correctly and comply with previously determined regulations/standards. As Dr. Simon mentions verification checks that " inputs= outputs". I also agree with @srg56 that its important to have realistic inputs to start with and that having a successful verification doesn't mean that the device is safe. As mentioned in the Bonezone article, "Design verification should be achieved with test equipment calibrated and controlled according to quality system requirements". The article also mentions using the design matrix as an important tool to ensure design inputs= design outputs. Like many have said its important to do think about the Verification stage earlier on when designing the inputs and that not performing appropriate verifications can be costly to the company. As a fun exercise, you should google image "medical device verification matrix", there are many interesting/informative matrices.

Everyone raised some good points regarding verification and its importance. Verification is indeed an essential process in design control, and it can also aid in risk analysis. By verifying every aspect of a medical device (dimension, function, biocompatibility, life expectancy), you are able to learn more about the device, and what can be done to minimize any risks. Every medical device has its risks, which must be known and presented to the FDA. As stated already, in order to have a successful verification process, it must be able to test all aspects of the device. Even if its something minor, all factors matter and tests should be thorough. I think that time is also very important in verification, which means that a lot of time should be spent. Time should be managed accordingly to allow for failed tests to be fixed.

Verification is the most important part in any project especially even in medical devices where there is interaction between devices and humans. Verification would make sure that device works in accordance with specification laid out in DSD. It all would make sure that all your inputs and out are in check whether all are in accordance with DID and DOD. If we have any issues or any error we can correct our DSD so as to follow FDA regulation. This would also make sure that device design is scrutinized under verification so that device quality is improved any will not be compensated at any point.

Good preparation of Design verification
Design verification Planning
Design verification Developing
Design verification Execution
Design verification Report

During the development stage of specification, the identification of verification activity is done parallel. This enables the designer to make sure that the specification is verifiable. So a test engineer can start detailed test plan and procedures. Any changes in specification should be communicated.

Planning for verification is concurrent activity with core and development teams. This occurs throughout the project life cycle. This will be updated as and when any changes are made to design inputs.

The design inputs must be developed including simplest verification activities which are unambiguous and verifiable.

The test procedures created during the development phase is executed in accordance with the test plan, strictly following them in verification activity.

This activity is performed at the end of each phase of verification execution.
The design verification report gives the detailed summary of verification results which includes the configuration management, test results for each type of testing and issues found during the verification activity.

If all the activity mentioned above are followed than there is no reason to have any issues with the process.

Verification is important because this ensures that the product meets the requirements for the design of the product. This is verified by executing a test plan to verify that it's within the accepted tolerance described in the requirements document. Verification makes sure that the product would not cause any harmful side effects due to a faulty design. It can also show the problems with the design during the development phase so alteration for the product can be executed to correct the issue. And, as mentioned above, this can save the company money from recalls and possible lawsuits from affected customers; as well as saving the company's reputation.

To add to what has already been said, Verification makes sure that you have objective evidence that user needs and intended uses are met. With a mindset to “break the system” thereby identifying any defects and functions that could result in hazardous situations leading to harm. As mentioned early verification testing; start testing design on simulator before the official completion of a physical system. This would help eliminate most especially software error and saves time.

As mentioned in previous posts design verification is an important step in design control process to ensure that the inputs are equal to the design outputs. Verification is an important step as the testing done during verification can satisfy both regulatory requirements and end user requirements ensuring a safe and effective product. One important step that can improve design verification step is ensuring that the the design inputs are clearly defined so that while developing a verification plan will be easier. With properly defined inputs it is a smooth transition in developing tests and verification checks.

I agree with what you have to say about the design verification. It is absolutely necessary to verify design before it goes out for production, because as an industry if you miss even a small thing, it would end up costing you millions, if not billions to repair the fault. If the device is harmful it will hurt the company even more, because they will need to recall and replace all those devices.

Early verification and a thorough verification are both necessary to ensure that no problems arise in the future. I agree that the cost to compensate for a mistake far exceeds that of taking preventative measures. By implementing multiple checkpoints throughout the process, and doing testing on batches based on a statistically representative sample size, a company can minimize the risk and control the costs of the verification process.

Verification is the process of ensuring that objective evidence are present and that the specific requirements are met. This process is usually done by inspections, tests, and in some instances analysis. I agree with merzkrashed that verification reduces commercial risks, risks to the users, and the costs of meeting the regulatory requirements. To add on these points, verification process ensures that design errors are detected early, and thus can be attended to before they become major. This early detection reduces potential failure in the field, which could impact on the health of the patient and even damage the reputation of the company.
In my opinion, having a design verification plan would greatly improve the verification process. This plan, therefore, ought to be developed early, not just before the verification process starts because it will be too late by then.