IOVV MATRIX FORM – INPUT OUTPUT VERIFICATION & VALIDATION

Description

This form provide a matrix representation of IOVV Design Input, Design Output, Verification & Validation basics for Design Control process according to 21 CFR 820.30.

Design verification is defined as, “confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” Design validation is, “establishing by objective evidence that device specifications conform with user needs and intended use(s)” (21 CFR 820.3). Simply put, verification confirms that the design output meets the design input requirements, while validation ensures that user needs are met by the medical device. For a simple visual relationship between them, see the following figure:

To highlight the differences between the two, let’s say a user need is that the “device will be stable during use.” This user need could then generate the corresponding design inputs of “device will not tip over under 20 pounds of load” and “settling time will be less than 5 seconds after movement.” Tests could be created and performed on appropriate samples to characterize tip-over force and settling time in order to verify that the device meets each of these design inputs. To validate the device, on the other hand, engineers would use a completed production version (or equivalent) of the device to demonstrate that the user need of stability has been fulfilled during actual or simulated use.