Design validation is just user testingDesign validation is just user testing

This is something I have heard a lot recently. But it’s not true. The Quality System Regulation 21 CFR Part 820 includes requirements for design controls. The regulation requires design validation to ensure your design or design changes will meet both defined user needs as well as your defined intended uses. All of these must be defined in your design input requirements documentation.

February 17, 2011

2 Min Read
MDDI logo in a gray background | MDDI

This is something I have heard a lot recently. But it’s not true. The Quality System Regulation 21 CFR Part 820 includes requirements for design controls. The regulation requires design validation to ensure your design or design changes will meet both defined user needs as well as your defined intended uses. All of these must be defined in your design input requirements documentation. The regulation also requires that design validation be done under actual or simulated use conditions with production or production equivalent units. If design validation were only user testing, the regulation would not allow for simulated use conditions.

FDA clarifies this in their Design Control Guidance for Medical Device Manufacturers, “The requirements which form the design input establish a basis for performing subsequent design tasks and validating the design.” And under Validation Methods, “Many medical devices do not require clinical trials. However, all devices require clinical evaluation and should be tested in the actual or simulated use environment as a part of validation. This testing should involve devices which are manufactured using the same methods and procedures expected to be used for ongoing production. While testing is always a part of validation, additional validation methods are often used in conjunction with testing, including analysis and inspection methods, compilation of relevant scientific literature, provision of historical evidence that similar designs and/or materials are clinically safe, and full clinical investigations or clinical trials.”

Design validation is really what happens near the end of the design or redesign of a medical device, it is done as a set of various activities to answer the question, does this design solution actually perform and function as I intend it to and does it meet my user needs. Design verification activities provide theoretical assurance that the design is appropriate in regards to your defined design input requirements, design validation provides evidence beyond theoretical that the device you designed is truly safe and effective within the context of those same design input requirements.

Denise Dion is the vice-president, regulatory and quality services at EduQuest, where she provides advice and guidance regarding FDA's regulation of drugs, biologics, medical devices, and food.

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like