The document explains the differences between design verification and design validation in medical device development, emphasizing their importance in ensuring compliance with FDA standards. Design verification involves evidence that design outputs meet input requirements, while design validation confirms that the device meets user needs and intended uses. It highlights the need for well-defined, testable design inputs to streamline the verification process and stresses the importance of proper documentation throughout these activities.

1. Design Verification vs Design Validation
By: Madison Wheeler
Every medical device company should be familiar with the terms design verification and design
validation. You will normally see these terms grouped into what is colloquially known as “V&V”
activities, but medical device firms must understand the difference between the two. Although
both activities are crucial to the design of a medical device, the functional difference between the
two distinguishes how firms should conduct them.
To start, the FDA defines design verification as activities that are performed to provide evidence
that design outputs meet design input requirements, or that specified requirements have been
fulfilled. This typically includes testing, inspections, and measurements but can also include
analyses like fault tree or thermal. Manufacturers should apply whatever verification techniques
aregenerally acceptedpractices for the technology integratedintotheir device.1 The biggest pitfall
manufacturers find themselves in when it comes to design verification is writing vague, un-
testable design inputs. This leads itself to make verification activities cumbersome and,
sometimes, near impossible. Development teams should keep verification in mind when defining
design inputs because they will have to test them down the road. Design inputs that are specific,
clear, and actionable will lend themselves to be easily testable and thus make the whole process
much easier for the team. The earlier the development team starts thinking about testing, the
better the outcome.
The next half of “V&V” is design validation, which is defined by the FDA as “establishing by
objective evidence that device specifications conform with user needs and intended use(s).”2 This
is the part of the product development where you prove your device meets the user needs and
intended uses defined in the beginning stages of the process. Design validation testing should
include everything from the device itself, to the instructions for use and the packaging. This phase
of product development intends to make sure that your device, and every component of it, fulfills
intended use. The device should be validated either under simulated or actual use and include
intended environmental conditions.
Even seasoned medical device firms can sometimes struggle with “V&V”. Not only is it important
to understand the functional differences between verification and validation, but also how
activities foreachone shouldbe completedand documented.Ifyou needhelp with medicaldevice
product development, EMMA International has a team of in-house design controls experts that
can help. Contact us at 248-987-4497 or email info@emmainternational.com to see how we can
help your team get your device to market!
1 FDA (March 1997) Design Control Guidancefor Medical Device Manufacturers retrieved on 09/21/2020 from:
https://www.fda.gov/media/116573/download
2 FDA (April 2019) 21 CFR 820.3 Definitions retrieved on 09/21/2020 from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.3