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September 22, 2023

Review of Qualio as QMS Software

Dr. Oliver Eidel

Key Facts about Qualio as QMS Software


QMS Features

Yes, this is a specialized QMS software which contains QMS-specific features like electronic document signing and document versioning.

Requirements Management

Yes, this is specialized requirements management software which enables you to manage your regulatory requirements in a compliant way.


Free trial

No, you can't try this software out for free - you have to purchase it based on sales demos.

Data exportable

No, you can't export your data in a structured way and are probably locked in.

Text editor

Yes, this software has its own text editor, that means you can create and edit documents directly in the software.


Yes, this software has a cloud-hosted option.


No, this software does not have a self-hosted option.


Pricing model

Secret pricing

Typical price

Unknown, price increases with user count

Minimum commitment

12 months


Company ownership


Company profitability

No, this company is losing money.

Qualio is another QMS Software you can choose. We’ll be adding more information to this page later, so check back soon! :)

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!

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