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Articles QMS Software

April 4, 2024

The True Shadiness Of QMS Software For Medical Devices

Dr. Oliver Eidel

If you want to bring a medical device to market, it’s likely you’re also looking for QMS software. And if you have no idea what any of those things are, then here’s a quick primer! As always, I’m grossly oversimplifying everything.

Software, Medical Devices & “Quality Management”

If you’re developing software, that software becomes a medical device if it is involved in providing diagnoses or treatment to patients (yes, simplifying here). And that again means that you need prior approval before bringing that software to market, because countries generally only want safe medical devices to be on the market.

So you have to create a crapton of documentation which, among other things, proves that your software is safe and doesn’t hurt patients. Makes sense!

Authorities call this “quality management”, and setting up the right documentation and processes means you’re setting up a “quality management system”, or QMS in short. I’m not entirely sure how huge stacks of documentation relate to product quality, but oh well, I didn’t come up with that naming.

Now! There’s also software which helps you set up this QMS, and that’s typically called QMS software. No surprises there. What is surprising though is that this industry is extremely shady, so let me tell you a bit about this in today’s article!

The QMS Software Sales Process & Prices

You might think that purchasing QMS software is as simple as purchasing any SaaS software, like Google Workspace or Slack.. yeah, right, nope, this is not the case.

Their websites only have those “schedule a call” or “contact us” buttons, and you’ll have to attend a call with a “sales specialist”. Typically, those are people who have neither technical nor actual regulatory experience as their main job is to only close sales. So they won’t really be able to answer any questions about how their software solves your problems, and instead they’ll give you a pre-defined software tour, just like a robot.

The hugely ironic thing is that, even though they’re a sales person, they likely won’t be able to tell you how much you will have to pay for their software. Here’s why: In the QMS software market, their shady company goal is to assess you and your company to see how much money they can extract from you. Two examples:

a) You’re a small startup in an Asian country with not much money. They’ll quote you a low price, because they know you don’t have much money and the likelihood of you purchasing is low anyway. So their main goal is to win you over as a customer to make some money, and then lock you in (see below) and possibly raise prices later.

b) You’re a mid-size startup in Europe and just recently raised millions of Euros. They’ll quote you a high price, because they know you have lots of money and you won’t necessarily be scrutinizing their quote very much because your startup’s goal will be to grow fast, and not to save money everywhere. You might easily receive a price which is 3-5x higher than the price for the startup in Asia, but the crazy thing is that you’re getting exactly the same software!

After your sales call, they’ll discuss internally what sort of offer they can send you.

If you haven’t noticed yet, you shouldn’t sign that offer, because everything about this is shady. But in the tragic case in which you do, you’re now locked in.

Oh, and you know what the biggest problem is? You didn’t even get a trial account. You only saw a sales person walk you through the software, but you never got to try it out for yourself. And this is on purpose, because they know their software sucks, so if you’d have any chance to try it out, you wouldn’t purchase.

So don’t sign the offer. Because if you do, here’s the next problem.

The Lock-In And Crazy Long Contract Period

Once you’ve signed a QMS software contract with one of the shady companies, you’ll be locked in for anywhere between 1 and 3 years. Yes, that long - crazy! You can’t cancel the contract before that time.

So, regardless of whether their software sucks or not, you no longer have a choice, because you’ve paid a super high price for it - around 15-20k€ per year (~50k€ for 3 years!), from our experience. And you can’t get out. That’s crazy!

To make the lock-in even more insane, even if you’d want to switch the QMS software provider for your medical device and money wouldn’t be an issue, you wouldn’t be able to, because there’d be no way to export your data - and this is on purpose.

Sure, you can export crappy PDFs, but you won’t be able to export any sort of structured data. You’re screwed. But it gets worse.

Locked In? Time For Upsells

See, you didn’t even purchase the full software yet, because they probably gave you some sort of “startup” offer. Initially, that may have sounded good (everyone likes discounts), but now you’ll notice that you’re actualy even more screwed. And that’s because you only purchased a limited feature set, and a limited number of user accounts.

Need an additional feature? Pay more money for them.

Want to launch an additional product? Pay more money for another product.

Your team grew from 3 to 10 people? Pay more money to get 7 more seats.

This is beyond crazy. From my experience, the biggest problem is the one with the user seats, because most startups grow at some stage, so almost all of them run into this problem. There are some workarounds, but they’re all terrible: You could move some of your documentation to a system where user seats are cheaper (e.g. Google Drive) - but now you have documentation in multiple systems (ugh). Or, you could “share” user seats where multiple people use the same login credentials, but this will become a huge mess because you might need to track e.g. who created a certain document (ugh!).

The sad reality here is that you have to cough up the money now.

A Better Way

So - those are the biggest problems in the shady industry of QMS software for medical devices. I’ll stop ranting right there for now. Let’s focus on what would be a better way instead.

First off, your decision on QMS software for your medical device should be made rationally. That means you shouldn’t base your decision on a sales call with a sales person. Instead, you should try it out for yourself! Create a trial account and play around with the software. If you get stuck somewhere, ask the sales person (chances are, they can’t help you). Ask yourself: “Can I see myself using this for the next few years? Is it intuitive and is it saving me time? Is it worth the money?”.

Next, don’t get locked in. Don’t sign multi-year contracts. We live in the 21st century, and all other SaaS providers on this planet offer monthly plans with monthly cancellation and monthly payments. Because in the unlikely case in which you change your mind and conclude “this software sucks”, you should be able to cancel soon and limit your financial downside.

Also, speaking about lock-in: Choose a QMS software which has a feature to export structured data. Because being able to cancel your contract every month is not enough, you also need to be able to migrate your data to another system, even if that system is a simple on like Google Drive or GitHub.

And finally, choose a QMS software company which doesn’t have a philosophy of shady upsells. Instead, take a look at which features you get from the start and how far they’ll get you.

So that’s how you choose the right QMS software for your medical device. And if you haven’t noticed by now.. yes, we also offer QMS software, and yes, I went into this market because I thought we could make a change - and our (many) customers prove us right!

Our QMS software, Formwork, has everything mentioned above: There’s a free version (lifelong!) and a paid version. You can try out the paid version in a free trial yourself (start it yourself - no sales call!). Our prices are transparent, you don’t have to ask us - just check out the Formwork page. Also, there literally are no upsells at all, because the paid version includes unlimited user accounts (yes, seriously, unlimited!), documents and medical device products.

And, best of all, you can change your mind anytime. You can cancel your account any time (online!), and you only commit for one month at a time. We offer an automated, structured data export so you can move your data to any other system if you like.

All of that is great, and our customers are passing audits with flying colors. But one sad aspect remains: Some people still choose other QMS software for medical devices. I hope you’re not one of them.

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

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

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

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No QMS on this planet will save you from creating crappy software.