Show the FDA you mean business with top-tier regulatory compliance software

Make your FDA inspector happy.
Get your drug or device cleared first time.

Regulatory compliance management software for FDA clearance



The Food & Drug Administration is the life science gatekeeper for 330 million people in the world's largest economy.

Getting your life-saving product to market means hawk-like inspection in accordance with some of the world's highest quality and compliance standards.

Some companies never make the cut.



The FDA wants life science companies to digitize their quality approach. 

eQMS platforms like Qualio make compliance natural and automatic by boosting control, sharpening visibility and unlocking complete control of the quality landscape.

Electronic quality =
unshakeable FDA compliance.

Regulatory compliance software: how it works

FDA 21 CFR Part 11 compliance

  • All major system actions, from document review to training completion and event close-out, underpinned by Part 11-compliant e-signatures
  • Incorruptible audit trails give complete traceability and accountability
  • GDocP and ALCOA+ system guardrails give you a controlled, compliant single source of truth for all your quality records

FDA 21 CFR Part 820 compliance

  • Provides all functionality for a holistic, digital medical device QMS, from design controls to training and CAPA management
  • Embed a risk-based, right-first-time approach underpinned by automated workflows and audit trails
  •  Used by hundreds of medical device companies to demonstrate quality and compliance and get their devices to market

510(k) submission

  • Easily combine and control all the ingredients of your 510(k) submission, from device safety data to substantial equivalence documents
  • Build a mature and digitally connected quality, risk and design control approach for a safe, cleared device
  • Shave months from your prep time

Premarket Approval (PMA) submission

  • Prove you have the robust quality system you need for a Class III medical device
  • Pinpoint gaps, cut risk and enjoy end-to-end, real-time visibility of your device's design and development pathway
  • Pull design elements straight from your other systems with instant integration


  • Automated digital control of documents, training, quality events, suppliers and design controls embed the manufacturing best practice of the Quality System Regulation
  • Eliminate manual admin and refocus your time towards continuously improving good practice
  • Keep up with FDA expectations with an agile, scalable, cloud-based eQMS connecting all corners of your business

FDA clearance resources


Everything you need to know about 510(k) submissions

Access our comprehensive end-to-end guide for your medical device's FDA 510(k) submission.

Read the blog post

What your QMS needs for
FDA & ISO regulation

Do you know what your QMS needs to make your FDA inspector happy? Find out with our webinar.

Watch the webinar

Don't just take our word for it!

Hear from our many happy customers

"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"When I recommend Qualio, one of the first things I say is: you're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources.
That's unique in this industry."
Becki N.
Quality & Regulatory Lead, Synthego
“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
"We looked a lot at how Qualio worked, its user interface, and the technology behind it. It was by far the freshest, most logical eQMS system out there."
Dmitry F.
Chief Technology Officer, ViQi
"I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
"Qualio’s become a verb here. When people need things, Qualio is the word that’s used."
Chris R.
QA Associate, AGADA Biosciences
"There are other eQMS providers that are very well-established, but not particularly accessible.

Qualio is not overly complicated. It gives us those foundational aspects of a quality system in a way that people can actually get behind."
Phil C.
Quality Manager, Bond Digital Health
"The perfect QMS system for a start-up. Everything, from validation to migration and training, was a positive experience."
Drew M.
Director of Quality, ECM Therapeutics
"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of an FTE. 

Qualio has given us one more staff member in a company where we throw nickels around like manhole covers!"
Mike T.
VP of IT & Information Security, xCures
“The cost of our Qualio licenses is insignificant compared to what we've saved by just improving our processes.”
Peter B.
Director of QA, Watchmaker Genomics
"The Qualio team made a big difference to our company by providing amazing help and guidance at a critical time in our QMS development."
Jackie L.
Managing Director, Auxilio Pharmaceuticals
"I entered a world with Qualio where quality is no longer a hassle."
Fedora B.
Co-Head of Biopharma Corporate Finance, JMP Securities
“We evaluated all players on the market and came up with Qualio as the best balance of price, capability, and quality of support.”
Jeffrey B.
CEO, FifthEye
“Once you understand how Qualio works, it's really easy to plan out processes and put them into place within the QMS.”
Sara V.
Quality Manager, Leaseir Technologies
"Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
"Qualio is far superior to other
systems I've worked with in the past.
The flexibility has been mind-boggling."
Michael H.
QA Director, TriMed
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
"Document control took anywhere from 5 hours to 3 days. Now things get done in hours, even minutes. I can send training out in seconds now. Qualio has made my life 100% better!"
Angela P.
QA Manager, Akadeum Life Sciences
"Qualio helps me sleep better at night.
Having that structure for everyone to work within is essential for us to really succeed this year in getting onto the market and staying compliant."
Heather U.
CEO, EvoEndo
"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
"Qualio has been great to work with. We implemented an entire QMS with them! Intuitive functionality, friendly staff."
Kim K.
Executive VP of Operations, VirTrial
"I feel 100% ready in our 510(k) and ISO 13485 preparations.
Qualio let us bring quality in-house in a way that will make us successful."
Hilary B.
VP of Regulatory & Quality, SimBioSys
"With other vendors, we felt like just a number.
But this is like a true partnership. Qualio has definitely changed our world."
Eric D.
Director of Quality Assurance, Expression Therapeutics
“We’re building a quality product. So we bought a tool that gives us a quality culture. Instead of pushing
quality to one department, Qualio breaks down that barrier.
Daniel A.
Chief Technology Officer, InVivo Bionics
"When you're using paper, you're not moving forward. You can't.
Now we're so streamlined, we're finally making progress. We're talking about bringing a new product into design controls right now.
I don't think that'd be possible if we didn't have Qualio."
Ami A.
Director of Ops & Quality Management, NeuFit
"I’ve never been more confident in my 27 years of being audited."
Lowell H.
Director of Quality Assurance, Restech

See how real American life science companies
use our regulatory software solutions to get to market