Design Verification and Validation

Both design verification and design validation are important parts of the design controls process. People sometimes mix the two because in both processes you just check if the expected outcome is what you had previously expected. In the case of design verification process, you're making sure that your design outputs comply with your design inputs. In other words, did you create the device properly? 

On the other hand, design validation proves that the device's design satisfies user needs and purposes you wanted to be achieved during the process. In other words, did you create the right device? Design inputs are planned in a way that will let them reflect all functional, performance, safety and regulatory requirements.  

What are design verification best practices? 

CFR 21 Part 820.3 states: “Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” In simpler terms, are you ensuring that the outputs of your design meet the design inputs? More often than not, the verification involves various tests and trials but verification can include other methods as well, like inspection and analysis. Regardless of the method used, the goal of verification is to ensure that design inputs are fulfilled and this is why a successful verification process starts with clearly defined design inputs.  

What are design validation best practices? 

The aim of design validation is to demonstrate that you have designed the appropriate device. This implies that the medical device is fit for the users’ requirements as well as the intended applications. Or, as per the FDA “The term validation refers to establishing by means of objective evidence the capability of a specific use to be fulfilled”. 

There are numerous best practices almost all design validation processes must involve: 

• The process of design validation must come with the prototypes produced at the commencing phase. This means that the devices which are the part of the design validation should be completed under conditions similar to those of manufacturing and produced by means of drawing and specifications laid down by the professionals in production line.  

• When it comes to the validation of designs, such a step should include clinical assessment. It is impossible not to involve end-user(s) and carry out device testing – either in the simulated or real environment. Simulation usually entails utilizing mathematical modeling techniques. In this case, you need to check how your device compares to similar devices.  

• Test the device in the environment where it is going to be used. Thus, there are cases when a device should work in different conditions, including moving from a room to a place where it will still perform the appropriate functions.  

• Don’t forget about packages and labels. A medical device is not just a piece of hardware. It includes a label, operating instructions, package, and everything inside the package. Validation should cover everything. 

The two main components of a high-quality QMS implementation driving both compliance with regulations and operational excellence are verification and validation. The verification process focuses on assuring that the product is created in line with its specifications and requirements, while the validation procedure involves confirming that the product meets both the needs of the users and requirements of the operation in real life. 

Organizations that clearly understand their verification and validation processes will be able to arrange their quality processes properly, use resources optimally and effectively, and prove their compliance with the rules in the course of audit.