Understanding the Distinction Between Verification and Validation?

In the world of medical device development, two crucial terms often come up: verification and validation. Let's delve into these essential concepts to gain a better understanding of their roles and importance.

Verification and validation are distinct elements of the medical device testing process. Verification, as defined by the FDA, is the process of "confirmation by examination and provision of objective evidence that specified requirements have been fulfilled." This process checks whether the requirements were met during the development process. Verification tests sub-systems like software architecture, specifications, high-level design, and database design, ensuring that your design outputs match your design inputs.

On the other hand, validation is the testing process that proves the device you built works as intended for the consumer. According to the FDA, validation is the process of "establishing by objective evidence that device specifications conform with user needs and intended use(s)." This process tests the device itself or the user's interaction with the device, checking whether the product built meets the needs of the consumer.

Medical device verification requires three elements: the model, the requirement, and a method. The success of verification depends on the process that precedes it, including understanding user needs, designing the product based on those needs, and producing outputs that reflect the inputs. Verification involves static testing techniques, while validation involves dynamic testing techniques, such as usability studies, pre-clinical studies, or clinical trials.

While verification finds issues early in the development cycle, validation finds issues that the verification process can't identify. With the right verification and validation testing controls in place, a smoother product design and development process is facilitated, and a product that meets consumers' needs is delivered.

Failure to develop such controls can lead to software anomalies that require a correction or removal of the device, which could affect patient safety, create legal issues, or damage the company's reputation. The value derived from verification and validation of medical devices goes beyond regulatory compliance, ensuring the delivery of a safe, effective, and reliable product to consumers.

Our medical device validation and verification services can help ensure your medical device works as it should and meets regulatory requirements. By partnering with us, you can rest assured that your medical device is in good hands, and you're on the right track to delivering a product that meets the needs of your consumers and adheres to the highest standards of quality and safety.

For more information about the differences between verification and validation, and how they can benefit your medical device development process, feel free to contact us. We're here to help!