Which QMS Software Should We Choose?


We're a startup developing software as a medical device and we're wondering which QMS software to choose. They all seem so similar.

Short Answer

If you don’t have any prior regulatory experience: Don’t look for QMS software right now. Instead, learn more about what you need to do (read articles on our website).

If you already know what you’re doing: Compare QMS software in our QMS software overview. Your best bet is probably Formwork.

Long Answer

You might expect me to be super-biased and shout “Formwork!”, but actually my answer to this question (which startups ask me very often!) is “probably no QMS software at all, unless you really know regulatory compliance well”. Let me backtrack for a bit and give you an example.

Imagine you want to write a novel. You have no prior experience as an author. Now you come to me and ask me “which text editor should I choose to write my novel?”.

The somewhat obvious answer here would be “why are you thinking about a text editor when you have no clue how to write a novel in the first place?”. And that would make perfect sense, because you should learn more about writing first before thinking about the tools you’ll be using.

Those things shouldn’t be mixed up: First you need to understand what you need to do (writing the novel or your compliance documentation) before you start thinking about how you can do it more efficiently (with a great text editor or QMS software).

These two things unfortunately often get mixed up by startup founders. They expect QMS software to teach them about regulatory compliance, and that’s just not the case.

So: Learn about regulatory compliance first, and only then go on a search for QMS software. If you don’t know much about regulatory compliance, stop reading here and head over to the Blueprint which is a good entry point into all the other articles on this website 🙂

QMS Software Differences

Now, if you are looking for QMS software, how do they differ?

I’d argue that, feature-wise, most QMS software is mostly the same nowadays. It’s a shady industry (yes, seriously), so the main differences are in the degrees of shadiness: How long do companies lock you in contractually, how much does the price go up when you need additional user seats, how easy is it to export your structured data if you want to switch providers, etc.

Most companies lock you in for around 2-3 years (yes, seriously – that’s crazy!), their prices go up significantly when you need more than ~3 users (also crazy!) and you can’t export your structured data if you’d want to switch providers (how is this not illegal?).

I suppose that’s where Formwork is different: It’s only a one-month commitment, you get unlimited users and you can export your data at any time. We also have a free tier and a free trial of our paid tier, all things which our competitors don’t have, because they prefer you to purchase based on only a sales call.

Recently (2024) quite a few of our startup customers passed their MDR audits.

So that’s the pitch, haha.. even if you don’t choose us, you can still continue to benefit from our website and all the free stuff we put out here – articles like this one, but also our free templates and videos. It’s truly our mission to make medical device compliance more transparent and accessible to all.

And if you are interested in Formwork, check it out here! And, if you’re considering other software, too, we’ve created a QMS software overview with which we try to create more transparency in this very intransparent market.

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 consulting? We’re a small company, so we can’t take on everyone – but maybe we have time for your project? We guide startups from start to finish in their medical device compliance.


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