Qualio Price: What We Know So Far

Dr. Oliver Eidel
Updated October 1, 2024
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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, typically something like 1-3 “complete” seats which can create and edit documents etc. So, considering that actually everyone from your company needs access to your eQMS software (e.g. for user trainings), I, um.. don’t know how that’s going to work, but good luck.

Each additional seat is going to cost you significantly more money. Crazy!

While Qualio’s pricing page does show different feature tiers (Foundation / Growth / Scale, at the time of writing), each of them doesn’t have a price and only links to a “Request pricing” button. Hm. Not very transparent.

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’re getting for that, yeah, I wonder about that, too. In my understanding, they’d just need to push a button to set up your eQMS instance and I’m not really sure how any additional work might realistically take place. But maybe we’ll learn more about this in the future (I don’t have high hopes).

Qualio Minimum Commitment / Contract Duration

The typical minimum contract durations we’ve heard from Qualio is three years. That’s crazy long for a startup! And guess what, you have to make this decision without ever getting a trial account as they only show you a demo in a 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.

Qualio Lock-In

One huge drawback of most eQMS software vendors, including Qualio, is that they don’t allow you to export all your data in a structured, machine-readable way. That means that it’ll be very hard for you to switch eQMS software providers if you ever want to.

This is crazy! So if you choose Qualio and end up unhappy with its price (or anything else), you’re likely stuck with that wrong decision forever.

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 get locked in and see prices go up significantly when your company grows.

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 (!). It starts as low as 49€ / month for early-stage startups, which is (checks notes) 42 times cheaper than Greenlight Guru or only ~2% of its price. Yep. I guess you should check it out unless you’re willing to overspend 42x (!) 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.

On a different note: Do you still have lots of questions about the EU MDR and would you like to talk to a human? No worries! Just book a free 30-minute consulting call.

Or, if you don’t like talking to humans, check out our Wizard instead. It’s a self-guided video course which helps you create your documentation all by yourself. No prior knowledge required.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to automate your compliance, look no further. We’ve built Formwork, and it even has a free version!

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