So you’re looking for enterprise QMS software for your medical device compliance, and you’re wondering which software to choose. You’ve checked out a few websites from QMS software vendors. You don’t really understand the difference between products

In the meantime, you’ve been contacted by some very sleek salespeople of various vendors. They pushed very hard to set up a call with you. In those sales calls, it sounded like their software is the best thing which has been created since Steve Jobs invented the iPhone. Besides solving all your regulatory problems, their software also appears to solve world hunger and nuclear fusion. Additionally, it will magically make your company regulatory-compliant.

But will it? Should you buy it?

I wouldn’t. And I think you shouldn’t, either.

Purchasing enterprise QMS software is one of the worst decisions you can make for your company. If you’re now thinking “damn, that blog post is kinda biased and personal”, hell yes this is personal! Let me elaborate.

Some time ago, we launched our own eQMS software, Formwork, which marked our entry into the QMS software game. We thought: All QMS software out there is crappy and their sales practices are super shady. So if we build something which is not-crappy and has a fair, transparent pricing model, we should have a good chance of being successful with it.

And yes, it worked out - companies started purchasing Formwork, and they love it. So all is well in middle earth?

Not quite!

Sometimes, just sometimes, a company leaves the well-trodden, beautiful path of Formwork and gets enamored by the dark forces of enterprise QMS software. The salespeople behave quite similarly to the evil imperator in Star Wars who convinces Anakin Skywalker to join the Dark Side, promising that Anakin can save his wife from certain death if he purchases their enterprise eQMS software. Quite similar,y those enterprise sales people promise you that your regulatory pain is going to go away if you join their dark side, i.e. purchase their software.

This turns out to be a false promise.

But then it’s already too late, because enterprise QMS software vendors lock you in by requesting prepayment of a year’s worth of fees, and you can’t export any of your data. The ship to safe shores has sailed and you’re stranded on the Death Star! You’ve become yet another Darth Vader, living in constant anger that you’ve chosen the wrong side, unable to revert your decision.

B2B sales are not rational, and enterprise QMS software sells many false promises. Let’s look at each of them and see how you can avoid wasting your money. There’s also one (very specific) exception in which enterprise QMS software may actually be a good fit for you. Read on to see when that’s the case.

Pretty much every SaaS software on this planet has a free tier which allows you to try it out and see whether you like it. This is not the case for enterprise QMS software. Instead, salespeople show you shiny slides during your call. That way, they compensate for the fact that the actual user interface of their software is insanely crappy and can’t be used by normal human beings.

How can you avoid that? Request a demo account with full features and try it out in a realistic setting for at least two weeks. Don’t just create placeholder content in it. Try it out for real, like you would use it in real life.

If you end up thinking “huh, I don’t understand how to use this”, you might be on to something. Or is it your fault that you’re unable to understand their complex software? Hell no - good software has great usability, even for newbies. If you can’t use it, it’s crap.

By the way: Formwork has a free tier (our Community Edition) which you can try out immediately. Just sign up and get started! We’re also happy to trial-upgrade you to the Pro version. Also, our customers love Formwork’s usability because it’s so simple, but you bether see for yourself.

Steve Jobs famously said that enterprise customers are confused when making purchasing decisions. This also applies to enterprise QMS software. Commonly it’s the CEO talking to salespeople who show them shiny slides and heavily overpromise on what the software can deliver. This will lead to catastrophic decisions, because the CEO has neither tried the software nor will be impacted by it in the future because they’re not using it.

Instead, the CEO will make their purchasing decision based on what the salesperson promised. It’ll be a top-down decision - the CEO decides and the poor regulatory people have to live with that crappy decision for the rest of their life at the company. If that sounds like a train wreck to you, you are right.

What might be a better solution to this? Easy. Just enable the regulatory people and software / hardware engineers to make the decision. They should try various QMS software out with their real-world use cases and assess which one suits their needs best.

How would you do this? Also easy - make the purchasing and pricing of QMS software so affordable and transparent that it becomes just another SaaS purchase, not a heavily-debated vendor-supplier purchase. Formwork has transparent pricing, monthly payments via credit cards, and no complex offer-contract-dance for getting started. Just sign up and pay.

Enterprise salespeople are not your friends. They are incentivised to close as many sales as possible, irrespective of whether their software is a good fit for their customers. They have hard goals of how many sales they must make per quarter.

So it doesn’t come as a big surprise that they will overpromise and underdeliver. You ask them for a specific feature you need? Sure, they’ll develop it, as soon as you purchase. Will your QMS be completely set up once you use their software? Sure, it has all you need, just send us the money. Will the Jira integration magically work and magically import all your development documentation? Of course, just sign the contract.

If it just were that simple. As a rule of thumb: Don’t trust any promises made by enterprise salespeople. If their software currently doesn’t have a certain feature, don’t assume it will ever get build.

Many vendors nowadays promise that they’ll set you up with a “complete”, ready-to-use QMS. As a CEO, you might think that this saves you a lot of time an instantly solves your regulatory pain. This is not true.

What does that mean in practice? The vendor will hire a bunch of people to copy-paste some document templates into your QMS folders (think of it like a Google Driver folder). In those templates, they’ll put your company name in certain places so that the documents look like they belong to your company.

But does this mean your QMS is done? Unfortunately not. Now you just have a bunch of documents with your company name in it. If you’d ever get audited, you’d still need to understand those documents and be able to explain them to auditors. You’d also need to adapt those so that they reflect the reality at your company.

By the way: Our templates are free, and they tend to be better than templates of QMS vendors! So why would you ever get a QMS vendor to give you their subpar templates if you could just use ours for free?

Many companies ask about a Jira integration for their eQMS software. And I always ask companies why they need a Jira integration for their QMS. After consulting 60+ companies, I haven’t seen one company in which such an integration would have made sense - saving work or removing redundancies.

In short, the promise of a Jira integration is “it will magically use your data from Jira and you don’t have to re-enter stuff in your new eQMS software”. The reality of regulatory compliance is that the documentation you need doesn’t exist in your Jira (or GitHub) at all - you need to re-create it anyway.

The best example is a software specification. Does you Jira have a clear software specification which lists all software features for each version? Or is it just a jumbled collection of user stories and tickets? If it’s the latter, you can’t re-use it for regulatory compliance anyway.

So the Jira integration won’t help you. But people often don’t know that. That’s why, when enterprise salespeople tell them “we have a Jira integration and it’s great”, they buy their software. Sad.

Generally speaking, I don’t like pay-per-seat pricing. It incentivises companies to create less user accounts, and it incentivises users to share their login details. Not cool. That being said, there are some fair points in favor of per-seat pricing: Larger companies pay more, and that’s okay, because they usually use the product more.

Linear per-seat pricing is okay - for each seat, you may X Euros (or Dollars) more. Like for Slack.

Non-linear per-seat pricing is shady - like, the first 10 seats are free, but starting with the 11th seat, each seat costs XXX Euros (where XXX is a ridiculous sum).

Many enterprise eQMS vendors have non-linear per-seat pricing. If you’re a startup, they offer you a great initial deal with, say, 5 seats included, but once you want to grow, you’re screwed. And you can’t migrate to another provider because they don’t allow you to export your data (by the way, in Formwork you can - with our batch-export).

That’s why per-seat pricing often ends up being a bad deal. Did you know that Formwork has a fixed price with unlimited user accounts?

By now you might think that I hate enterprise QMS software. And to some degree, you might be right! That being said, I do see one use case for enterprise QMS software. Let me describe two example companies to you:

Company #1 is a startup consisting of five people. They have neither fixed processes nor documentation. They just develop and ship software and want to bring that to market as a medical device. They want a software which is simple to use and helps them create their documentation in the simplest, most straightforward way. They don’t need to customize it. They just need an opinionated software to get stuff done.

Company #2 is a large corporate company of a few thousand people. They already have an existing QMS in place. They’re also a manufacturer of hardware medical devices. They now want to develop an app and bring it to market as a medical device. Their QMS is a gigantic mess, a mix of paper-based documentation and Word documents (ugh!). Someone also introduced Jira and five other tools in which some documents can be found. They’re looking for an eQMS solution to gain efficiency but need super-heavy customization because they’re using some obscure workflows and tools.

While enterprise QMS software will be a terrible fit for company #1 (choose Formwork!), it might be a reasonable fit for company 2. If you need heavy customization, have lots of existing (hardware) devices on the market and have different company departments with hugely contradicting requirements for an eQMS software, an enterprise solution might be right for you. (You might have gotten the hint that corporate companies often come up with weird, irrational requirements for eQMS software. In my experience, corporate companies are no longer rational actors anyway. But don’t worry, enterprise sales people cater exactly to these needs).

If your company is small and you want to focus on shipping great products, don’t choose enterprise QMS software. Choose Formwork or roll your own on GitHub, Google Drive, etc.

If your company is a large corporate company with no productivity, but lots of political infighting and irrational requirements, go for the enterprise software!