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Updated May 24, 2023

Choosing a Notified Body

Dr. Oliver Eidel

If you’re anything higher than class I, you need a Notified Body to certify your software as a Medical Device.

What the Hell is a Notified Body?

They are privately held companies like TÜV SÜD, Dekra and BSI. Their task is to assess whether 1) your company has implemented an ISO 13485 - compliant Quality Management System (i.e., “is the company compliant?”) and 2) whether the Technical Documentation of your product is sound (i.e., “is the product safe?”).

In the US, this is done by a government-backed institution, the FDA. In Europe, you get to choose your Notified Body and have to pay them for everything. There certainly is some irony in that. In my understanding, that’s the definition of a conflict of interest, but for some reason I’m missing something obvious here. Because that’s how Medical Devices get certified in Europe.

Which One Should You Choose?

Notified Bodies differ in their strictness and in their pricing. As a startup, your priority should be to get through the audit with minimum effort while ensuring that your software is safe for users. That being said, I wouldn’t recommend Notified Bodies which are known for their strictness - nobody earns brownie points (or money) for superb regulatory compliance.

This is about shipping products which help patients and enable a company to become profitable.

Other important things to keep in mind:

Message me for further insights :)

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you're still lost and have further questions, reach out any time!


If you have any questions or would like to share your opinion publicly, feel free to comment below. If you'd like to reach out privately, send us a message.

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