automotive design validation process pdf

The ventilator is suitable for use during in-hospital transport of patients. A user need, for example, might look like the following. Or might include transport via ambulance or by air. But what are they actually trying to do? “Transport” might include moving the patient within the hospital.

The user wants to move patients while they are on the ventilator. Let’s imagine we’re building a ventilator that keeps a patient breathing, and that the user wants it to work during patient transport.įirst, we must define our user needs. Official word from the FDA (21 CFR 820.3) states that design validation is “establishing by objective evidence that device specifications conform with user needs and intended use(s).”

We’ll begin with validation.ĭesign validation is a testing process by which you prove (“validate”) that the device you’ve built works for the end user as intended. That’s the simple difference as clearly depicted in the graph below.ĭesign validation: Are you building the right product? Design verification: Are you building the product right?īut you want more details and examples, of course. Are design outputs matching design inputs? Does the device work as intended for the end users? Design verification determines if you’re building the product right. What's the difference between validation and verification? Put simply, design validation determines if you are building the right product. Design Verification: What's the Difference?

6 Tips for Better Validation & Verificationĭesign Validation vs.

You’ll find her insights and examples throughout!įollow along or skip to the section you're after: and international device regulatory submissions. Note: To validate that this content would be useful to you, we connected with Megan Martin, a medical device V&V Consultant with over 30 years of experience in medical device V&V, medical device software, product and software quality, and U.S. Here we’ll explain what the two activities are, the difference between them, plus share tips for getting the most out of your efforts. If you develop products - medical devices, particularly - then you’ve heard the terms design validation and design verification (also called V&V).

Automotive design validation process pdf