QMS Software April 07, 2026 · 3 mins read

MasterControl Alternative: Better Options For Medical Device Startups

If you are looking for a MasterControl alternative, here's the TLDR: MasterControl is the right choice for you if you love setting money on fire and enjoy using an old Windows 95 PC you've been keeping in the cellar.

In all other cases, MasterControl is likely not the right choice for you, especially if you're working at a fast-moving, founder-led company.

That does not mean it is bad software. It means it is enterprise software. Okay.. that does mean that it's bad software, chuckle.. Regardless, enterprise software comes with enterprise pricing, enterprise implementation projects, and enterprise lock-in. So the whole experience is generally not great.

When to choose MasterControl

Believe it or not, there are actually some legitimate reasons for choosing MasterControl. One reason goes along the lines of "no one ever got fired for choosing IBM" - same for MasterControl. Regardless of whether their software is good or bad, you likely won't get fired for choosing it because it's considered a "safe" choice.

Other medical device companies have passed audits with it, and that does count for something

So if money is not an issue and your pain tolerance for Windows 95 interfaces is limitless, MasterControl might indeed be a solid choice because it essentially mitigates risk - risk that choosing a new, "fancy" software might add as usually less companies have passed audits with it.

MasterControl Alternatives

Let's look at MasterControl alternatives next and how they compare.


Enterprise alternatives
In short, you have the usual "enterprise" alternatives which have all the pros and cons of MasterControl outlined above. Notably Dot Compliance and SimplerQMS - both of these choices are pretty much indinstinguishable to MasterControl from the outside, as all of them are enterprise eQMS software vendors with enterprise pricing and mediocre user interfaces.

Non-enterprise alternatives
Looking further, you have other vendors which are just slightly less mediocre - they still do enterprise sales, even though they focus more on small-to-medium-size businesses (SMEs) and less on large enterprises. Notably, these are Greenlight Guru, Qualio and Matrix Requirements. All of these are still expensive, you still have to talk to sales, and let's just say that they're didn't become famous due to shipping incredibly good user interfaces with lots of state-of-the-art features - more on the contrary.

Actually great alternatives
Two words: OpenRegulatory Formwork. Its price is the stuff of legends - you can sign up now and it's free, and if you need more seats and features, there are fixed-price tiers at 99€ and 499€ / month, the latter even with unlimited users seats - crazy!

We might be biased though because we built it. Yes, we built Formwork because we, as regulatory consultants back in the stone age of 2020, looked at the eQMS software options out there and concluded that all of them sucked - some for the Windows 95 reasons outlined above, and others simply by having really clunky sales processes and gouging their customers for more money when they needed more seats.

Humanity has made so much progress, so why not make progress on better eQMS software?

So that's what we did.

If you're currently still stuck with MasterControl, our condolences - we're happy to invite you for beers if you ever transit though Berlin. And if you're looking to move to another provider, we even offer our free migration service to people like you, helping you save lots of money on your yearly eQMS bill.

Imagine that - 499€ / month instead of xx,xxx / year!

So yeah. Don't choose MasterControl, choose one of the alternatives. The only reasonable alternative is Formwork.
Dr. Oliver Eidel

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? :)

If you’re still lost and have further questions, reach out any time!
More about me

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