Verification and validation sound similar, but they mean different things. Verification checks if the product was made right based on the design and requirements. Validation checks if the final product actually meets the user’s or customer’s needs. For example, verification could test if a medical device matches the technical drawings, while validation would test if it works well for patients. Both steps are important because a product can pass verification but still fail validation. In industry, verification usually happens before validation.
Verification is the process of confirming that design outputs meet the specified design inputs. This typically involves documentation in the Design Verification Plan (DVP) and summarized in Design Verification Reports. These might include mechanical testing data, electrical safety testing, software code reviews, or dimensional inspections comparing the prototype against design drawings and specifications. Supporting documentation often includes test protocols, traceability matrices, and raw data records that demonstrate objective evidence of conformity.
Validation ensures that the final product fulfills its intended use and user needs. It typically occurs later in the design process, under real or simulated use conditions. The key documentation includes a Design Validation Plan, Design Validation Report, and records of user needs testing, usability studies, or clinical evaluations. In FDA-regulated environments, this may also include human factors engineering reports and clinical trial summaries for higher-risk (Class II/III) devices. In industry, both processes are captured within the Design History File (DHF), which provides a complete record of compliance with CFR and ISO requirements.
I am currently taking another Medical Devices class and we actually covered this in the first lecture. Validation is the process where there is objective evidence that client needs are met. It's basically me asking, did I make the right device where the client needs are met? Verification is basically the process where there is objective evidence that certain requirements are met. It's basically me asking, did I make the correct device based on certain requirements? If I have met client needs, then I will know that I designed the correct device and that is validation. If I have met specific requirements and guidelines, then I will know that I have designed the device the correct way and that is verification. So in short, if you meet client needs, that is validation since you are making the correct device that is for those client needs. If you meet requirements and guidelines, that is verification since you are designing the product in the correct way that fulfills those requirements.
To put it another way, verification is typically carried out during development through inspections, testing, and analyses—such as comparing dimensions, materials, or performance metrics to design specifications. On the other hand, validation frequently entails clinical assessments or real-world testing to determine whether the product functions as intended in the hands of the user. What would happen, in your opinion, if a team concentrated too much on verification and not enough on validation? Could a gadget please the end user even if it satisfies all technological requirements? And in order to avoid last-minute surprises, do you think validation should start earlier in the design phase, perhaps through early user feedback or prototype testing?
Even though validation occurs later in the design controls process, it is based on the user needs, which are determined at the start of the process. Therefore, it would be beneficial to consider the required validation methods as early as possible. The same can be said for verification. After the design inputs are approved, the verification procedures and tests can be considered for later.
Insufficient validation raises safety concerns for the product. Perhaps, for design validation, the clinical evaluation with the user was missing data or did not resemble a real-world condition, or the product’s packaging & label were not included. Poor process validation means the product may or may not be safe because there is insufficient data to support that the manufacturing process is stable. These potential risks can result in an ineffective product that injures the user. A product can meet its specified requirements, but if it does not benefit the user, then the design controls process requires adjustments.
Validation and verification are both crucial parts of the medical device development process, but they serve different purposes. Verification ensures the product meets the specifications outlined in the design- essentially asking, if the device was built correctly. This involves testing against design requirements such as dimensions, and material properties. Validation, on the other hand, ensures the device fulfills the end-user and clinical needs, asking, was the correct device built. This typically involves usability studies, clinical evaluations, and feedback from real-world environments. In practice, strong verification ensures technical accuracy, while strong validation ensures the device is actually safe, effective, and valuable for patients and clinicians.
While I don't currently work in the medical device industry, the understanding and learning of the difference between verification and validation are essential and closely related cogs in the design control process. Verification is the involvement of checking that the design outputs mee the design inputs; this can range from confirming dimensions and tolerances to electrical or software performances. This can be done through other processes discussed such as inspections or reviews. Validation differs in that it focuses on whether the final product actually meets the user needs and performs as intended in real world applications. An example of this would be a hospital device that passes all electrical and mechanical tests, but the users (such as clinicians) find it difficult to operate safely or utilize in an appropriate manner. Both of these steps are crucial in medical device development .
From my experience as a QC/QA intern at Case Medical, I’ve seen how validation and verification are similar but serve different purposes. Verification is more about checking that a product was made correctly according to the design. For example, I often perform dimensional inspections on sterilization trays using calipers to make sure they meet the specs on the drawings. Validation, on the other hand, focuses on whether the product actually meets the customer’s needs and works the way it’s supposed to in real situations. Working in quality has shown me how both steps are important for making sure a product is safe and reliable before it reaches the customer. A product can pass all the verification tests but still fail validation if it doesn’t perform well in real use. How do you guys think companies can make sure that both processes stay connected so products not only meet standards but also satisfy users?
