Author: John Campbell | Date: July 7, 2021
Medical device verification and validation (V&V) are crucial steps in the medical device development process. But what’s the difference between the two, and why do we need them? 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.
Keep in mind, 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(s),” 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.
|Checks whether requirements were met||Checks whether the product built meets the needs of the consumer|
|Finds issues early in the development cycle||Finds issues that the verification process can’t identify|
|Tests sub-systems like software architecture, specifications, high-level design and database design||Tests the actual product|
|Comes before validation||Comes later in the process|
|Involves static testing techniques||Involves dynamic testing techniques|
|An internal process that’s used in development or production||An external process that seeks acceptance from users|
Verification and validation are two different and distinct processes that complement each other in determining whether the system or application conforms with requirements and meets its intended purpose. Auditors and regulatory bodies require well-documented verification and validation plans, test protocols and results to ensure the device meets requirements and is fit for use.
The value derived from the verification and validation of your medical devices spans far beyond that of regulatory compliance. With the right verification and validation testing controls in place, you’ll facilitate a smoother product design and development process and deliver a product that meets consumers’ needs. Failure to develop such controls can lead to software anomalies that require a correction or removal of the device and could affect patient safety, create legal issues or damage your company’s reputation.
You don’t have to go it alone—we can help! With our medical device validation and verification services, you can rest easy knowing your medical device will work as it should and meet regulatory requirements.
To learn more about the differences between verification and validation, contact us.
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