4 W’s of Design Review

Jul 16, 2019 | Product Development, Quality + Regulatory, Risk Management

Developing a medical device is a complex business, with many opportunities to experience pain. And one of those moments that keeps cropping up is Design Reviews – they’re a requirement for the US, covered in ISO 13485 and you know what? They make good business sense.


If you had a clear picture of what a Design Review is supposed to do for you, what would you do?


In this bite-sized video, we’re talking through Design Reviews. We don’t have time here to go into too much detail, so do get in touch if you’d like to go deeper.

What is a design review? Here’s what FDA has to say:

“a comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, capability of the design to meet these requirements, and to identify problems.”21 CFR § 820.3(h)]

In other words, it’s an in-depth, honest, review of the available information for your medical device project, as a stage gate to determine if you’re ready to move to the next stage of development. It’s intended to provide feedback on existing or new issues, project progress.


When should I do a design review?

According to the FDA:

“it depends”!

You’ll have at the very least, 3, at the end of each of phase, as a stage gate. Of course, you can add other design reviews, especially during the earlier phases, to use as a check of which concept(s) to develop further, check whether you’ve finished design evolution and can freeze the device design, and so on.

How should I tackle a design review?

1. Put them into your development plan! It may seem obvious, yet you’d be amazed as how often they’re left out, and then come as a surprise

2. Have a clear objective or purpose for each design review, such as “to select our preferred concepts to take on to development” or “to evaluate if we’ve done enough to verify the device design”

2. Prepare well for them – know what data, which information should be reviewed, to satisfy the review purpose

3. FDA is often quoted as saying “if it isn’t written down, it didn’t happen”, so document, document, document


Who should be involved in design reviews?

A common response is “oh, it’s the design engineer” or “that’s something that quality do”

Actually, they involve teams – and here’s a clue as to who should be involved

At least one person needs to be independent of the project – to ensure there’s “a fresh perspective” (FDA words, not mine)

Design Review 1 – will assess if you’ve got a device concept that appears to meet users’ needs

Design Review 2 – determines whether your chosen device design is ready to take to the next level – scaling up for full-blown production

Design Review 3 – takes stock of what’s been done, are you ready to get approval, to prepare for launch.


As you watched this video, you’ll have started to think about how your project should be making the best of this requirement. You may now want to get some guidance on how to go about it more effectively.


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