Updated in 08/2026: Qualio still doesn't publish prices, but its pricing page is much more specific nowadays: An implementation fee applies to every plan, edit users and regulatory frameworks are limited, and multiple add-ons cost extra. Qualio also launched a proper API and expanded its exports, so we've corrected our old lock-in section below.
If you're looking for eQMS software right now, you might be wondering what the Qualio price is. Don't worry, you're not alone! We've worked with 150+ companies in the medical device space and many of those were able to share some feedback with us on what the Qualio price range might be.
As a huge disclaimer, this is not official information about the Qualio pricing - we're simply writing down what we've heard from medical device customers. If you'd like to receive an "official" quote, you'd have to head over to the Qualio website.
The pricing, even on their website, is very intransparent, because no specific amounts are mentioned - you have to schedule a sales call with them, and then they'll send you a custom offer, based on how much they think your company might be able to pay (yep).
Worse yet, it's hard to compare different offers from different eQMS software providers, because each one contains slightly different features, a different amount of user seats and different add-on fees e.g. for additional medical devices or user seats.
Suffice to say, it's a very intransparent and shady market!
So now let me share what we've heard from our customers about Qualio prices.
If you're looking for eQMS software right now, you might be wondering what the Qualio price is. Don't worry, you're not alone! We've worked with 150+ companies in the medical device space and many of those were able to share some feedback with us on what the Qualio price range might be.
As a huge disclaimer, this is not official information about the Qualio pricing - we're simply writing down what we've heard from medical device customers. If you'd like to receive an "official" quote, you'd have to head over to the Qualio website.
The pricing, even on their website, is very intransparent, because no specific amounts are mentioned - you have to schedule a sales call with them, and then they'll send you a custom offer, based on how much they think your company might be able to pay (yep).
Worse yet, it's hard to compare different offers from different eQMS software providers, because each one contains slightly different features, a different amount of user seats and different add-on fees e.g. for additional medical devices or user seats.
Suffice to say, it's a very intransparent and shady market!
So now let me share what we've heard from our customers about Qualio prices.
Qualio Pricing
How much does Qualio cost? Short answer: At least 25k€ per year. Per year!
Most of our customers are small startups, i.e. 5-10 people. Those who have told us about Qualio prices typically mention prices in the range of 25k€ per year. Yes, that's right, we're talking a mid-five-digit sum. Per year! And that price only includes very few user seats for the software. In the past, we heard of quotes with 1-3 "complete" seats which can create and edit documents etc.; as of 08/2026, their pricing page states that the Foundation plan includes 5 "edit" users and the Growth plan 10, plus unlimited "basic" (read-only) users. So, considering that actually everyone from your company who does real QMS work (drafting, reviewing, approving documents) needs an edit seat, I, um.. don't know how that's going to work, but good luck.
Each additional edit seat is going to cost you significantly more money. Crazy!
While Qualio's pricing page shows three tiers (Foundation / Growth / Scale), none of them has a price and each one eventually sends you to "Request pricing". The Scale tier is literally labelled "custom pricing", in case you were still holding out hope.
The page does at least make the limits clearer now. Foundation includes five edit users, five quality-event templates, three regulatory frameworks and two development-tool integrations. Growth includes ten edit users, unlimited event templates, five frameworks, up to three integrations and the new Developer API. Additional edit users, regulatory frameworks and multiple instances cost extra. Qualio also says subscriptions are annual and implementation usually takes 30-60 days. So we know much more about what is being priced; we still don't know the price. Hm.
Most of our customers are small startups, i.e. 5-10 people. Those who have told us about Qualio prices typically mention prices in the range of 25k€ per year. Yes, that's right, we're talking a mid-five-digit sum. Per year! And that price only includes very few user seats for the software. In the past, we heard of quotes with 1-3 "complete" seats which can create and edit documents etc.; as of 08/2026, their pricing page states that the Foundation plan includes 5 "edit" users and the Growth plan 10, plus unlimited "basic" (read-only) users. So, considering that actually everyone from your company who does real QMS work (drafting, reviewing, approving documents) needs an edit seat, I, um.. don't know how that's going to work, but good luck.
Each additional edit seat is going to cost you significantly more money. Crazy!
While Qualio's pricing page shows three tiers (Foundation / Growth / Scale), none of them has a price and each one eventually sends you to "Request pricing". The Scale tier is literally labelled "custom pricing", in case you were still holding out hope.
The page does at least make the limits clearer now. Foundation includes five edit users, five quality-event templates, three regulatory frameworks and two development-tool integrations. Growth includes ten edit users, unlimited event templates, five frameworks, up to three integrations and the new Developer API. Additional edit users, regulatory frameworks and multiple instances cost extra. Qualio also says subscriptions are annual and implementation usually takes 30-60 days. So we know much more about what is being priced; we still don't know the price. Hm.
The Shady Set-Up Fee
It doesn't get better though. Like other enterprise QMS software companies, as part of the price, Qualio has the concept of charging new customers a "setup fee" which can range between 8k€ and 20k€.
If you're wondering what you get for that: Qualio says its onboarding team guides the implementation and that most customers go live in 30-60 days. Fair enough - my old "they just push a button" rant was too simplistic. Whether that work is worth an 8k€-20k€ fee is another question, and those amounts are still customer data points rather than public Qualio prices.
Update (08/2026): What is official now is the policy itself: "Implementation fee applies to all plans." They also list additional fees for extra edit users, regulatory frameworks and multiple instances. At least they're transparent about being intransparent now.
If you're wondering what you get for that: Qualio says its onboarding team guides the implementation and that most customers go live in 30-60 days. Fair enough - my old "they just push a button" rant was too simplistic. Whether that work is worth an 8k€-20k€ fee is another question, and those amounts are still customer data points rather than public Qualio prices.
Update (08/2026): What is official now is the policy itself: "Implementation fee applies to all plans." They also list additional fees for extra edit users, regulatory frameworks and multiple instances. At least they're transparent about being intransparent now.
Qualio Minimum Commitment / Contract Duration
Qualio's public pricing page confirms an annual subscription. Separately, the longest minimum contract duration we've heard from customers is three years. That's an important distinction: Three years is a customer-reported contract term, not Qualio's published minimum for everyone. Either way, you have to make the decision without a publicly advertised self-service trial; the website sends you to a demo and sales call.
So, let me spell this out for you again: Are you willing to commit ~75k in total to a software which you haven't tried out yourself, only based on a shiny sales demo with a salesperson who doesn't even know much about medical device compliance?
Well.. good luck.
Personally, I think that any software as a service (SaaS) should have a monthly cancellation option, because in the fast-moving world of startups, who knows whether you need a software in 3, 6 or 12 months!
The final point I'd like to talk about is lock-in.
So, let me spell this out for you again: Are you willing to commit ~75k in total to a software which you haven't tried out yourself, only based on a shiny sales demo with a salesperson who doesn't even know much about medical device compliance?
Well.. good luck.
Personally, I think that any software as a service (SaaS) should have a monthly cancellation option, because in the fast-moving world of startups, who knows whether you need a software in 3, 6 or 12 months!
The final point I'd like to talk about is lock-in.
Qualio Lock-In
Correction: This section was out of date. Qualio now documents exports for documents, training, events, suppliers and the audit trail, and in 2026 it launched a REST API for documents, events, training, users and more. That's a meaningful improvement, and it would be unfair to keep saying that Qualio has no structured export.
Would I call migration easy now? Not without testing it. A collection of exports and API endpoints is not automatically the same thing as one complete export containing every document, relationship, review and approval. If you're evaluating Qualio, ask them to migrate a sample project out again before you sign. That's a much more useful test than asking whether an Export button exists.
Would I call migration easy now? Not without testing it. A collection of exports and API endpoints is not automatically the same thing as one complete export containing every document, relationship, review and approval. If you're evaluating Qualio, ask them to migrate a sample project out again before you sign. That's a much more useful test than asking whether an Export button exists.
Conclusion: Purchasing Qualio
To sum up, purchase Qualio if:
- You're willing to spend ~25k€ per year on a software
- You're willing to make that decision based only on a sales call without a trial of the software
- You're willing to accept an annual (and potentially longer) commitment and test the migration export before signing.
As you might have noticed, it's a shady industry.
At OpenRegulatory, we set out to change that. We're creating more transparency in the medical device compliance field, even if it's not in our own best interest: We're sharing all our medical device compliance templates for free and we've created a QMS software overview to help companies choose the right software.
And, yep, we saw how shady the eQMS software market is which made us develop an eQMS software of our own in which we'd do everything in a better way: Our eQMS software, Formwork, has transparent pricing, monthly billing and unlimited users (!). Early-stage startups can start on the free tier or the 99€ / month tier, which is (checks notes) around 20 times cheaper than a typical Qualio quote. And even our top tier at 499€ / month - unlimited users, all features - comes in at roughly a quarter of Qualio's entry price, without any implementation fee. Yep. I guess you should check it out unless you're willing to overspend on your eQMS software.
If you're interested further, check out this video in which I show you the shady marketing practices of eQMS software vendors.
At OpenRegulatory, we set out to change that. We're creating more transparency in the medical device compliance field, even if it's not in our own best interest: We're sharing all our medical device compliance templates for free and we've created a QMS software overview to help companies choose the right software.
And, yep, we saw how shady the eQMS software market is which made us develop an eQMS software of our own in which we'd do everything in a better way: Our eQMS software, Formwork, has transparent pricing, monthly billing and unlimited users (!). Early-stage startups can start on the free tier or the 99€ / month tier, which is (checks notes) around 20 times cheaper than a typical Qualio quote. And even our top tier at 499€ / month - unlimited users, all features - comes in at roughly a quarter of Qualio's entry price, without any implementation fee. Yep. I guess you should check it out unless you're willing to overspend on your eQMS software.
If you're interested further, check out this video in which I show you the shady marketing practices of eQMS software vendors.
