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[
 ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/large_detail/large_detail_239fdb020d69919db5553a9bf0b0e605/qualio.jpg "Product Avatar Image")
 
 ![Reward for good Qualio reviews](https://images.g2crowd.com/uploads/report_medal_translation/image/38917/medal.svg "Reward for good Qualio reviews")
](/products/qualio/reviews)

[

Qualio

](/products/qualio/reviews)

(781)4.4/5

Qualio is a quality management and compliance platform built exclusively for life sciences companies. It helps medical device, pharmaceutical, biotech, and digital health organizations accelerate regulatory approvals, stay audit-ready, and scale compliance operations without adding headcount. Our platform manages the full range of quality processes, including document control, training, CAPA, change control, supplier management, risk management, and design controls, all in one validated system, supporting FDA 21 CFR Part 11, ISO 13485, EU MDR, MDSAP, GxP, ICH Q10, and other life sciences requirements. Move faster without compliance as the bottleneck. Qualio connects regulatory affairs, quality, and R&D in one platform, with deep integrations into Jira, Azure DevOps, GitHub, Salesforce, and other tools teams already use, removing the handoffs and manual documentation that typically slow product development down. Get to market faster. Automated gap analysis and multi-framework compliance mapping cut audit preparation time by 80%. Reusing evidence across FDA, ISO, and EU submissions has helped customers shrink market entry timelines from 9 months to 3-4 months, while cross-mapped documentation accelerates 510(k) submissions, CE marking, and international expansion. Scale without growing your compliance overhead. Customers report a 99% reduction in quality administrative time and have eliminated $150K-$300K in annual consulting costs by replacing manual processes, driving 5X ROI within 2 months. See risk before it becomes a finding. End-to-end traceability connects requirements, risk assessments, CAPAs, and product changes, with risk-based alerting that flags gaps before they turn into FDA 483 observations, warning letters, or audit findings. Customers have passed ISO 13485 certifications and sponsor audits with zero major nonconformances using this always-on monitoring. Qualio serves life sciences companies from pre-market startups to established enterprises, with the SOC 2, HIPAA, and pharmacovigilance capabilities growth-stage companies need, deploying faster than legacy eQMS vendors while maintaining the validation rigor required for FDA inspections and notified body audits.

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•

over 3 years ago

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[
# What does Qualio do?
](/discussions/what-does-qualio-do)
What does Qualio do?

[

Quality Management Systems (QMS)

](https://www.g2.com/tags/quality-management-systems-qms)[

Medical Quality Management Systems (QMS)

](https://www.g2.com/tags/medical-quality-management-systems-qms)

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 (true)\<0\>0\>Upvotes (false)

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6 Comments

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G2

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•

over 4 years ago

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[
# What is Qualio?
](/discussions/what-is-qualio)
What is Qualio?

[

Quality Management Systems (QMS)

](https://www.g2.com/tags/quality-management-systems-qms)[

Medical Quality Management Systems (QMS)

](https://www.g2.com/tags/medical-quality-management-systems-qms)

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 (true)\<0\>0\>Upvotes (false)

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3 Comments

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G2

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•

about 3 years ago

More Options 
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[
# What is Qualio used for?
](/discussions/what-is-qualio-used-for)
What is Qualio used for?

[

Quality Management Systems (QMS)

](https://www.g2.com/tags/quality-management-systems-qms)[

Medical Quality Management Systems (QMS)

](https://www.g2.com/tags/medical-quality-management-systems-qms)

* * *

 (true)\<0\>0\>Upvotes (false)

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1 Comment

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•

about 4 years ago

More Options 
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[
# What is Eqms quality management system?
](/discussions/what-is-eqms-quality-management-system)
What is Eqms quality management system?

[

Quality Management Systems (QMS)

](https://www.g2.com/tags/quality-management-systems-qms)[

Medical Quality Management Systems (QMS)

](https://www.g2.com/tags/medical-quality-management-systems-qms)

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 (true)\<0\>0\>Upvotes (false)

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2 Comments

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G2

Pinned by G2 as a common question

•

over 4 years ago

More Options 
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[
# What is QMS software?
](/discussions/what-is-qms-software)
What is QMS software?

[

Quality Management Systems (QMS)

](https://www.g2.com/tags/quality-management-systems-qms)[

Medical Quality Management Systems (QMS)

](https://www.g2.com/tags/medical-quality-management-systems-qms)

* * *

 (true)\<0\>0\>Upvotes (false)

* * *

2 Comments

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[Bogdan D.](https://www.g2.com/users/d2181ed7-8130-43e6-990d-e1203ebe72a0 "Bogdan D.")

•

over 5 years ago

More Options 
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[
# Google Suite Compatibility
](/discussions/50462-google-suite-compatibility)
Is Qualio a compatible solution for managing the quality system of an organisation using Google Suite? Are there any capability issues with how the solution is configure for example in managing documentation that is coming from Google suite rather than Microsoft?

[

Google Suite

](https://www.g2.com/tags/google-suite)[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

* * *

 (true)\<0\>0\>Upvotes (false)

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1 Comment

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 ![Rachel A.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Rachel A.")
RA

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[Rachel A.](https://www.g2.com/users/9307b970-bbce-4fec-87bb-6c40ff70004d "Rachel A.")

•

over 5 years ago

Medical Outreach Specialist at eHealth Technologies

Medical Outreach Specialist at eHealth Technologies

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[
# Do you all make any sections for actual video and hands on training for companies? If not I think that would be a wonderful additional feature for companies using Qualio for document signing.
](/discussions/41459-do-you-all-make-any-sections-for-actual-video-and-hands-on-training-for-companies-if-not-i-think-that-would-be-a-wonderful-additional-feature-for-companies-using-qualio-for-document-signing)
The website is always offering to give help with any questions the users may have. This is something I love to see on websites. Sometimes having a customer service representative there to answer questions is what we need to get to the correct place.

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

* * *

 (true)\<0\>0\>Upvotes (false)

* * *

1 Comment

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DY

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[David Y.](https://www.g2.com/users/7dc6b26a-b210-4606-a2e3-8681aceed513 "David Y.")

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over 6 years ago

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[
# Hello, I was wondering what is the duration of your Free Trial?
](/discussions/25092-hello-i-was-wondering-what-is-the-duration-of-your-free-trial)
Hello, I was wondering what is the duration of your Free Trial?

[

free trial

](https://www.g2.com/tags/free-trial)[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

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CJ

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[Courtney J.](https://www.g2.com/users/ca6c18b5-7bef-4a0f-b74e-b95b5f20fae4 "Courtney J.")

•

almost 6 years ago

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[
# Can I use Qualio for group training in a classroom?
](/discussions/34124-can-i-use-qualio-for-group-training-in-a-classroom)
It would be great if there was a feature where Qualio could be used by a group collectively.

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

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## Top Contributors in Qualio

1

 ![Grant H.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Grant H.")
GH

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### [Grant H.](https://www.g2.com/users/aba77bdb-d0d6-4cac-b4c2-f9829112758b "Grant H.")

Growth marketing / demand generation

3 pts

2

 ![Yogesh M.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Yogesh M.")
YM

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### [Yogesh M.](https://www.g2.com/users/6edf5506-b5bd-4e8b-a51d-12fc531837e4 "Yogesh M.")

L2 Support Specialist

2 pts

3

 ![Abbasali B.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Abbasali B.")
AB

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### [Abbasali B.](https://www.g2.com/users/88cb1ed0-ec6b-4bfe-91af-2217af5d0399 "Abbasali B.")

Test Engineer

2 pts

4

 ![Rachel A.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Rachel A.")
RA

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### [Rachel A.](https://www.g2.com/users/9307b970-bbce-4fec-87bb-6c40ff70004d "Rachel A.")

Medical Outreach Specialist

1 pt

5

 ![Bogdan D.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Bogdan D.")
BD

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### [Bogdan D.](https://www.g2.com/users/d2181ed7-8130-43e6-990d-e1203ebe72a0 "Bogdan D.")

1 pt