PRODUCT COMPARISON

Greenlight Guru vs. Qualio

Built for life sciences is not the same as built for medical devices. That difference shows up when you need IEC 62304 alignment, a connected design history file, and implementation support from people who've actually worked in the industry.

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Trusted by 1,000+
medtech companies
worldwide

Aligned with ISO 13485,
FDA QMSR, EU MDR,
and ISO 14971

Supported
thousands of
successful audits

What Greenlight Guru gives you that Qualio doesn’t

Qualio offers a basic starting point for document management and compliance, but medical device companies need more than that. They need a complete QMS that’s built for medtech compliance from day one.

Feature	Greenlight Guru	QUALIO
Medtech-specific defaults	✓FDA, ISO 13485, IEC 62304 built in	✗Typically requires configuration and customization
Time to validated QMS	✓Weeks, guided by medtech experts	✗Customers report months with external QA/RA consultants often needed
Design controls & traceability	✓Live DHF linking requirements, risk, and verification	✗Basic trace matrix. Teams report reverting to Excel or Jira
Jira / GitHub integration	✓Native Jira and GitHub integrations with bidirectional issue sync	✗Limited. Customers report this creates silos and duplicated work
Change control flexibility	✓Flexible, supports fast-moving software teams	✗Locked after first draft. Causes friction for SaMD
Post-market workflows	✓Connected CAPA, complaint, supplier control	✗Lacks automation. Teams typically must replatform
Implementation support	✓In-house medtech regulatory experts	✗Generic support. Limited medtech expertise
Data portability	✓File-type agnostic; Word, Excel, Google Docs	✗Proprietary editor. Exports are painful and expensive

See the difference

Why medtech teams choose
Greenlight Guru over Qualio

Our customers choose Greenlight Guru for an intuitive, scalable QMS solution that’s built just for medtech and
is supported by in-house medical device experts who are there to help at every step.

IVD / Scaling medtech
company

"All of our documentation, quality events, and training materials are connected in the system, and this makes it clear who is responsible for each action."

Petra ElischerQuality Manager,
Hart Biologicals

AI-Powered SaMD /
510(k) Clearance

"Greenlight Guru’s design controls module is powerful and the traceability present across the entire QMS is my favorite part about the software. It makes remote collaboration so much more effective.”

Crystal WomackQuality Manager,
Avenda Health

Class III /
Breakthrough device

“Greenlight Guru was instrumental in implementing our quality system. With them, we can bring safer, higher-quality medical devices to success while maintaining a quality culture.”

Maxime RochonDirector of QA and Clinical
Affairs, Puzzle Medical

Frequently asked questions

How does Greenlight Guru compare to Qualio?

Greenlight Guru is built specifically for medical device teams, with compliant defaults aligned to FDA 21 CFR Part 820, ISO 13485, and IEC 62304 from day one. The design history file (DHF) is built in real-time, which means audit readiness isn’t a scramble at the end of a development cycle. Native Jira and GitHub integrations ensure that engineering teams stay in their own tools while quality documentation happens alongside development, not in a separate system that no one maintains. Greenlight Guru also includes a thorough and efficient onboarding and implementation led by in-house medtech experts.   

Qualio is a general-purpose quality management system built on ISO 9001 standards, which means medical device teams typically need to hire consultants to manually customize it for medical device regulations and standards. Teams building SaMD or SiMD products in particular consistently find that its design controls module cannot handle real traceability, its change control process blocks fast iteration, and its lack of functionality in developer integrations creates friction and leads to low adoption across the Product and Engineering teams.

Can I migrate from Qualio to Greenlight Guru?

Yes. Greenlight Guru's onboarding and implementation program is designed to get teams up and running in weeks, not months. The process begins with a dedicated welcome call and implementation plan, followed by structured milestones covering system configuration, document and change management, design and risk management, and quality processes. Throughout, you work directly with a Medical Device Guru, an in-house expert who has worked in the industry, who guides your team through each phase. If you have legacy documentation from Qualio, the implementation process accounts for organizing and migrating that content as part of the structured onboarding plan.

Does Greenlight Guru have the same integrations as Qualio?

Greenlight Guru includes native integrations with Jira and GitHub, specifically designed for software development teams building software as a medical device (SaMD) and software in a medical device (SiMD) products. Qualio has limited functionality for developer integrations, which commonly creates silos between Product and Quality teams and forces duplicate documentation work.

Ready to see the difference?

Join 1,000+ medical device teams who built their quality system on a platform designed for medtech from day one.

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