Updated May 18, 2022

The Great Notified Body Survey

Dr. Oliver Eidel

Choosing a Notified Body is one of the most momentous decisions for your Medical Device company.

If your auditor is tech-savvy and pragmatic, you’ll be shipping software updates regularly, your business will do well and your employees will be happy. But if your auditor is nit-picky and technically incompetent, your company’s progress will grind to a halt while everyone scrambles to create additional regulatory documentation, asking themselves why the hell you decided to develop a Medical Device in the first place.

Case in point: We’ve heard of a company which had to submit each change to their MDD Class I device to their Notified Body - yep, a class I device which doesn’t even require a Notified Body! For some reason, the Notified Body wanted to make sure that every change is non-significant. (They had other devices which were class IIa or higher, that’s why they had a Notified Body).

Other Notified Bodies are more open to modern approaches, like using GitLab as a QMS tool. They’ll even do a remote QMS audit solely through GitLab, without clunky PDF exporting. That’s pretty cool!

So, what are the names of those Notified Bodies? But wait, would it be a good idea to share this sort of data here?

In my opinion: Probably not. Because our data is highly anecdotal! Our opinion on Notified Bodies is limited to the horror stories we hear from our clients. But for recommendations to be truly reasonable, they need to be data-driven.

That’s why, today, we’re starting the first systematic survey of Notified Body experiences. We call it The Great Notified Body Survey.

And that means we need your help! Our survey is designed in a way that you can provide data even if you didn’t end up working with a Notified Body. Like, if you were only in touch via email, you can still rate things like whether they were pragmatic, organized and technically competent.

Like Amazon reviews for Notified Bodies!

And if you’ve been in touch with multiple Notified Bodies, you can submit the survey multiple times - once for each of them.

Click here to take part in the survey now

Why are we doing this?

We think that experiences with Notified Bodies should be transparent so that startups can make informed decisions on which ones to choose.

And as Notified Bodies are privately-held, for-profit companies, the economic incentives of the broader marketplace should also apply to them. Just like on Amazon, if a seller makes a crappy product, people leave bad reviews and the seller sells less of their product. The same should apply to Notified Bodies: If they do a crappy job, they should no longer get any customers.

While it may be questionable whether for-profit companies should be doing independent audits at all (let’s not go there), it leaves us with a unique opportunity: We get to choose.

And to choose properly, we need reviews.

Click here to take part in the survey now

Where will the data be published?

We’ll publish the data here on our website and also make the raw data freely available - probably on GitHub.

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I work as a regulatory consultant for Healthcare software startups. I try to publish all my knowledge here so that startups can certify their medical devices themselves in the future.

If you're still lost and have further questions, just send me an email and I'll be happy to answer them for free. More about me

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No QMS on this planet will save you from creating crappy software.