When I started out as a consultant back in the stone age (2020), I was struck by how intransparent this industry was.

Want to download standards? Please pay money for a PDF. Need templates? Purchase them from consultants. Have questions? Ask a consultant, get billed by the hour.

I thought this sucked. Gatekeepers in this industry were optimizing for their own, short-term gains, while prohibiting advancement of the field as a whole.

I thought I could make a change, and that was how OpenRegulatory was born. I thought: As long as I can be profitable as a consultant, I can give away lots of stuff for free. That would enable startups who don’t have any funds to pay me to get their documentation done by themselves.

Since then, OpenRegulatory offers even more free templates, and nowadays they are so complete that you can essentially do an entire medical device submission by yourself, for free!

That’s amazing, and I’ve witnessed many startups enter the market who otherwise wouldn’t have been able to, because they built their company with their own savings, and paying a consultant was not feasible.

And, on the other side, I’ve heard from multiple Notified Bodies that they see many submissions based on the OpenRegulatory templates, and they generally like those, because they tend to be quite complete, yet also not exceedingly long. That’s awesome!

QMS Software: Formwork

In 2022, we took that even further by offering our own QMS software, Formwork. The thinking here was quite the same: If we manage to make this profitable, let’s give away as much as we can for free.

That’s how the Formwork Community Edition came to be, which (still) is probably the only, 100% free QMS software for document management out there. Unlimited users, too!

This was another stepping stone in supporting those bootstrapped startups, where 3 dudes or dudesses are sitting in a cold garage, furiously hacking away on their medical device prototype, willing to put in grueling hours and suffer unlimited pain, because they’re creating their MDR documentation by themselves. Mad props.

Still, there was a wrinkle: To make things profitable, we had to price the paid versions of Formwork quite highly: 499€ or 799€ per month.

Now - this actually isn’t a high price if you compare us to other QMS software providers. Those typically have higher prices, multi-year contracts, limited user seats and no data export (good luck with the lock-in). So, if you compare Formwork to those, Formwork wins easily, and many companies are slowly realizing that, too. I regularly talk to companies who reach out whether they can migrate to Formwork to save money, and they’re tired of dealing with their shady QMS salespeople.

So Formwork is cool, and the price point is great.

But here’s the problem: For the three dudes in the garage, 499€ per month is not great. And those dudes are not comparing Formwork to other QMS software, they’re comparing it to generic software which might do the job, but is priced much lower: Software like Google Drive and Confluence (ugh).

What usually happens next? I’ve seen this time and time again: The three dudes choose Confluence. Initially, they would be happy with their choice. But, a few months down the line, preparing their audit submission, the pain would start.

Creating and maintaining regulatory documentation in a generic tool which is not purpose-built is, at minimum, a full-time regulatory job. But, in reality, it’s much worse than that: Because it was not purpose-built, it has evolved into a gigantic mess of epic proportions, resembling a “Frankenstein”-like monster where different systems, plugins and custom scripts have been stitched together in a very broken way. And the output still sucks, because essential stuff (e.g. traceability) is missing.

So choosing Confluence, or Google Drive, or Notion usually ends up spawning this sort of Zombie-like apocalypse in your startup. Not great. But even worse, the founders only realize this when it’s too late. They’ve been using Confluence for a long time, preparing their audit submission, and only now realize that it’s a huge mess.

This is a lose-lose situation, because your options are:

• a) Clean up the mess: Postpone audit submission by 3-6 months.
• b) Keep the mess, but be screwed for the indefinite future because you’ll have to maintain it.

And the root case was somewhat our fault, because Formwork was too expensive for the three dudes in the garage.

That’s why, today, we’re introducing Formwork Starter: Everything in Formwork, at a much lower price, so that the three dudes in the garage no longer choose Confluence.

Formwork Starter: 49€ / month, Full QMS Software With Requirements Management

Formwork Starter is, quite literally, our full Formwork software at a fraction of its price. No strings attached!

It’s our offer to early-stage startups so that they don’t screw up by choosing Confluence.

We don’t like limiting user seats or storage, because both things lead to weird workarounds (shared user accounts etc.) and are shady anyway. That’s why we base this offer on a trust-based approach which looks at your company’s situation.

Specifically, to qualify for Formwork Starter, your company should have:

• No funding yet (private / public)
• No revenue
• 3 people or less working in it full-time, regardless of salary.

.. and they need to be sitting in a garage.

Just kidding. But the prior three points still stand. And once you have funding or revenue, simply reach out to us to upgrade to the normal price.

So now, there’s really nothing holding you back from choosing Formwork for your medical device startup. Give it a try!

For now, we’re testing Formwork Starter with a limited number of customers. Hit the “Contact us” button on the Formwork page to reach out if you’re interested!