Quality-driven growth at every stage

Trusted by 100s of global medical devices and therapeutics companies to enable quality-driven growth from startup to scale-up.

Medical Device Manufacturers


DeviceLab logo
DT MedTech LLC logo_220x100
FabriFoam logo_220x100
Flatley Engineering logo
Rapid logo_220x100
Second Heart logo
AMRA logo
Oxsonics logo_220x100
TekDry logo_220x100



Inimmune logo_220x100
passage bio logo
rowa pharmaceuticals logo (1)
Cilatus Manufacturing logo_220x100
Armis Biopharma logo_220x100
Avectas logo_220x100
synthego logo (1)
q biomed logo (1)
proscia-logo (1)

Contract Organizations

Linical logo_220x100
gefco forwarding services logo
KSE Scientific logo
Tempo-Automation Logo
T1D Exchange logo_220x100-1
Tucker Lab logo_220x100
nova biologics logo (2)
aravive logo
circuitects logo
Cirris-Systems-logo (1)
Subject Well logo


Life sciences and healthcare organizations trust Qualio across the world.

What our customers are saying.



Paul Maguire
CEO and Co-Founder, Arann Healthcare

I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us to reduce workload and paper trail.

Dr. Christopher Devine
Dr. Christopher Devine
President and CEO, Devine Guidance International

As consultants, we have the pleasure of working with the good, the bad, and at times, the ugly, when it comes to Quality Management software. Qualio simplifies the approach to effective quality management. The web-based software is intuitive, which greatly reduces the amount of time required for users to come up to speed with a new platform.

Drew M
Drew M
Dir. of Quality, ECM Therapeutics

The price point is great for a small start-up biotech company, and the software also has the ability to scale as needed. Everything from the validation, to the document migration to the initial training was a positive experience.

If you are looking for an affordable cloud based QMS system that incorporates all required features then I personally recommend to take a look at Qualio.

Joseph O
Joseph O
Quality Professional

We needed one place to do things. Before using Qualio, we were working over a mixture of different software. Qualio lets us do that, a one-stop shop for us.

Any questions we had around setup [or processes] were answered very quickly indeed. The great to be able to have proper traceability around the document-based processes.

Barbara Y
Barbara Y
Small Business Quality Professional

Qualio has allowed me to develop a complete medical device quality system for a small company in a way that is part 11 compliant, provides custom formatting, easy navigability, flexible assignments for roles and training, metrics, and specialty tools without breaking the budget.

Raymond G
Dir. Hospital & Health Care

I’ve worked for several companies that each have their own form of training and quality systems, Qualio is one of the easiest systems I’ve used.

David Hughes
David Hughes
CEO, Surfatek

Qualio enabled us to seamlessly work through the ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally.

Tara Fitzpatrick
Tara Fitzpatrick
Quality Manager, Rowa Pharma

Coming from a manual, paper-based system, it’s amazing how it all just works. Qualio has forever-changed how we manage quality.

Henk V
Henk V
QA Manager

We are a small biotech company ,with full compliance to QA requirements and Qualio fits all our need.

Christian S
Consultant CMC + QA

I like the very flexible approach that Qualio offers to deal with document type of information. A document can be basically everything from an SOP, over an HR file to an Equipment log. This is very powerful in particular in combination with the tagging feature. Tags allow you to categorize documents, limit their access to certain user (groups) and can even be used to set the scope of a document like an SOP in way that that you can adjust the scope without necessarily changing the document content. I also enjoyed the interaction with implementation team from Qualio, which was professional and friendly.

Gene V
Quality Manager

I'm a one man team and have Implemented Qualio in less than 4 weeks. If ease of use and quick importing of documentation, with the ability to tailor your system to your liking is what your looking for? Then Qualio is the software program for you. We're still discovering all the things we can do with it. Our HR department is jumping on board as well. We can create our own system the way like it, not the way some else has designed it for us. Very powerful tool to satisfy even the hardest outside auditor. Because it makes their job easier as well as your own. Buy it. You'll love it.

Kendal R
Research Faculty

The ease of use and tracking compliance. The system is intuitive and adaptable. So much better that SAP applications I have been in in the past. If I have an issue the chat is perfectly responsive. I have never had an issue that was not resolved or a chat that was left hanging for any length of time.

Mohammad Z
Mohammad Z

When I need a form, I don't go to anyone in the office. I go straight to search bar of Qualio and get a pretty updated one. Keeps all employees updated and not wasting time to ask for something.

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Bring your team, tools, and data together. Make compliance a breeze and ensure nothing gets missed.

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