Hi Hodafattel, I do not work in the industry, however, I can elaborate on each of the two terms which you have mentioned. Validation is quite important in a product, but it may not need to always be performed. Validation may be seen as the "extra mile" to make absolutely sure that things do not just work in theory, but also in practice as well. In you are working on devices which are dangerous or that may impact an individual's life then validation is an important process, because it is important that you do go the "extra mile" with these said devices.

I completely agree with the statement @cem34 made, though the reasonings are different in my opinion. Validation doesn't signify real-time functionality rather it ensures the efficacy of a product based on user input. On contrary, verification denotes inspection of a product based on its specifications. For example, someone wants to buy a car with greater legroom. To fulfill customers' demand, the manufacturer company designed a car with a legroom of 24 inches (6 inches more than usual). In this case, ensuring the car's legroom is exactly 24 inches is the verification. While for validation, we need two 7 feet tall persons taking a test drive and providing their feedback. However, validation is not always necessary for the medical device industry, if the clinical trial is not mandatory.

Validation is the process of ensuring the product you set out to make is correct. This means testing functionality and overall 'benefits' that the product may be advertised with. Verification is more involved with paperwork in the sense that it ensures the processes completed in order to achieve the end product are sound. In addition to the development process, verification also includes the proper documentation of your product in and out of development.

Verification checks whether a device meets specifications and standards. At this stage it is uncovered whether or not a device is being designed and developed in the correct way. Validation checks whether the device actually meets the requirements. During validation processes it is determined whether or not there is objective evidence that the device meets the requirements and customers needs. Validation activity can be done in a few different ways but the most common methods include tests, inspections, and analysis. Verification and validation are important in testing and quality management. The quality assurance team does verification activity and the R&D/testing team performs the validation activity. 

@cem34 I'd have to disagree with you. I believe that validation is incredibly necessary for a medical device. I could say that I work in the industry because I work with instruments that are use to screen for drug enzymes. These instruments have to go through a validation process especially with the quality control sets that run through them every day to calibrate them. However I can see how this would be different because my company is the only user. A verification process would be necessary for some final reviewer of a medical device before it hits the user market. 

In my experiences with validation and verification in the field, validation is the back and forth we have with customers to try and meet their needs. For example, at the defense company I used to work at, after being presenting with an issue and making a draft model and sharing it with the customer they would get back to us discussing what they thought of the model but from their point of view. Now when we'd discuss this with their fellow engineers the conversations were a lot more involved which would be the verification portion whereas when it were let's say the sales department they'd be more concerned of the validation so the customer checked off that our product did the job they were looking for.

My experience with design verification and validation is that both activities must have strategies developed in the planning phase of the project. For verification, the strategy varies depending on the type of design project. If it is a new product or a design change project, as mentioned above, the verification checks if the outputs meet the inputs via testing or via documentation that provides rationale proving outputs=inputs. Validation ensures that the product meets the customer needs. The validation strategy however varies between new products and changes to current products. For new products, extensive validation is typically needed, both design and process validation, as well as equipment and TM validation if applicable. For changes to current products, the validation may be simpler or not necessary depending on the complexity of the change, how it impacts the patient, and how it impacts the process.

In my industry, I have experience doing method validation and verification on our machines as part of our job. The main difference between validation and verification is that when you are validating something, you are checking if the customer/ the laboratory need is fulfilled based on previous meetings and agreements made. However, the stage of doing verification is the most tedious and time consuming as you have to make sure your code or design actually works and is functional and has no bugs or project critical errors. To do this may rounds of testing is done, which are outlined in a test document to make sure all the testing is done in a cohesive fashion. Verification is often the most important part of testing a method as this is often the final step before being released after clearing paperwork.

While I do not have any experience in the industry working with verification and validation, I have learned a lot about the processes in this course. Verification is the check phase of the design control process, which checks if the inputs produce the necessary outcomes. In order to check this, there must be a way to test the product, conduct the test, check the results, and determine if it worked and how to fix it if not. In contrast to the validation step, the verification step is required in the design control process. The validation step, however, comes after the verification step if there are changes to the product after verification, if a clinical trial is required, and/or if the product changes affect the user interface. To do further testing, validation includes using the product in living people, using the product in a cadaver, and/or having a physician try the product. This is to ensure that the inputs meet the needs of the user. With this information, it seems as though the validation process is a way to further test the efficacy of the product and gain user feedback.

I never gave the difference between validation and verification much thought. After doing so, verification is the process of ensuring that your product complies with the specifications and requirements you've written. "Did I build what I promised? Validation tests are conducted. how well you handled the business requirements that prompted you to develop them It's also known as acceptability testing or business testing. "Did I construct what I require?"

According to the lecture, there is a difference between verification and validation in most cases. However, sometimes the verification is interchangeable with validation. If the product that you are producing is verified and the input equals the output all specs are within the appropriate limits then the customer accepts that as validation of the product. Now once the customer uses the product to produce their own product or device that company will verify and validate the product/device. In my experience working in research & development to produce 1,3 propanediol, we verified on a small scale what the outcome results would be for manufacturing. These tests were sampled taking on mini versions (10L fermentation tanks) that contained GMO which yielded the by-product the manufacturing were producing in large scale batches. Before any batch was shipped to a customer the Quality Control Lab sampled the product (actual large scale batch sample) from beginning to end and performed validation tests and generated a report to attach with the product. If the product failed validation entire batches were halted and validation testing was repeated. The company takes validation seriously to send out good products and maintain good customer relationships. 

Medical device verification and validation (V&V) are crucial steps in the medical device development process. Verification and validation are necessary to comply with regulations and design a high-quality product that results in fewer mistakes, better repeatability, lower production costs and faster time-to-market. While verification and validation are both elements of the medical device testing process, they serve two very different but equally essential functions. In the simplest terms, verification determines whether the product was built right, while validation determines whether the right product was built. The FDA defines design verification as confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. In other words, verification tests whether your design outputs match your design inputs. Used to ensure the medical device design is on track per the requirements, verification typically includes tests, inspections and analysis on the various layers and sub-systems of the product. Medical device verification requires three elements: the model, the requirement and a method. Your verification is only as good as the process that precedes it. If you first seek to understand the needs of your users, then design your product based on those needs and produce outputs that reflect your inputs, your design verification should run smoothly. If there’s a breakdown in any of those steps, you could be looking at costly setbacks that delay time-to-market. Validation, on the other hand, is the testing process that proves the device you built works as intended for the consumer. Defined by the FDA as the process of establishing by objective evidence that device specifications conform with user needs and intended use, validation testing can be done through usability studies, pre-clinical studies or clinical trials. Unlike verification that tests the device at the sub-system level, validation tests the device itself, or, more specifically, the user’s interaction with the device.

I currently work at an industrial manufacturer; I have had experience with both validation and verification during my short tenure at this job. We manufacture industrial burners for various applications; for companies that are either, longtime customers seeking replacement parts or new customers looking for custom application burners. Those that seek specific replacement parts require that those parts match their existing setup; as such, we must verify the specifications of our parts in the shop. When creating custom setups for customers, I have to validate that our solution matches the customer's needs. Once the setup is fabricated, we must verify that those specs match our written specs.

Verification is a process of determining if the software is designed and developed as per the specified requirements. Validation is the process of checking if the end product ( such as software) has met the client's true needs and expectations. Verification is a static testing while validation is dynamic. Verification does not include the execution of the code which validation does.