Design control consists of nine parts. Parts five and six are for design verification and validation. Design validation may not always be required if the product has not changed since verification.
Design verification is a systematic process in the medical device development lifecycle that ensures the designed product meets the specifications provided in the design input document (DID). This step entails developing and carrying out tests, inspections, and assessments for each design aspect to guarantee accuracy. Essentially, it addresses the topic of whether the product was properly created. Verification is part of the PDCA cycle, specifically during the execution phase (Do). The results of these tests are documented in a verification document, ensuring a clear record of compliance.
Design validation is a phase in the medical device development process that ensures the final product satisfies the needs of the user and is suitable for its intended usage. This step extends beyond design verification and includes real-world testing to evaluate the product's performance in its intended setting. Design validation determines whether the correct product has been designed for the target audience. Validation, like design verification, is a step in the PDCA cycle, specifically during the execution phase. The validation protocol specifies the tests, passing criteria, and actions to be taken in the event of a failure.
In essence, design verification determines whether the product was developed appropriately based on specified requirements, whereas design validation guarantees that the product is appropriate for its intended consumers and objectives. However, all of the steps are the same. Does that sound right? Are there any further distinctions, or are they fundamentally the same thing?
well, its a good question. However, I can tell you an easy way to understand it.
All the inputs have an output. Each output is verified in verification. Tests are done here to check the output. Additionally, it is observed whether the output passes the test. Then all the tests are listed in a document.
In validation, user needs and intended use are tested. All the inputs need to be validated. Validation is required when 1)change is required after verification, 2)clinical trial is required 3)product change affects user interface
Verification and validation are similar processes but with different goals. Verification relies on testing the design requirements/specifications to ensure that the product is built/functions as designed. Validation is testing to ensure that the customer's requirements or needs are met. For instance, imagine a biomedical engineering company designing an artificial pancreas. Verification would be the testing to ensure that the pancreas works as designed, delivering insulin as needed to regulate blood sugar. Validation would be the testing to ensure that the customer is satisfied with the product and that the product functions as they envisioned.
Even though the overall structure is similar, in practice, they are executed differently because the actual tests in design verification are completely different that the tests executed for design validation. As the previous two replies explain, the goals for these tests are different - one is to verify that outputs meet inputs while the other is to validate the the final product meets the customer needs. Practically what does that mean: lets take a suture for example, the customer need may be that the suture is easily visible, the design input is that the suture will contain 70% red dye, the design output is a specification that details out the suture composition including the 70% red dye. For design verification, the test method may be a fabric color test that confirms that there really is 70% red dye, therefore the output meets the input. For design validation on the other hand, the test may be a set of surgeons that are asked to use the suture on a cadaver and evaluate where the suture is visible, thereby validating the final product meets the customer need.
