Regulatory software, Re-imagined.

Ship software faster. With Formwork.

Used by innovative medical startups to ship software faster.


Manage, review and sign your documents. In lightning speed.

No more clunky PDF exports and signing tools. Keep all your documentation in one place. Review and sign. Done.

Employee training. Without the nonsense.

Save time spent on lengthy in-house training sessions with attendance sheets. Define your trainings and let Formwork create your documentation.

Requirements Management - No Spreadsheets Needed.

Say goodbye to broken spreadsheets and complicated Jira setups. Fill out Formwork's simple forms and get your 62304-compliant requirements documentation done in days, not weeks.

Risk Management.
For Humans.

Risk management in Formwork is so intuitive that even your mom will understand it.

Automatically Generate Your Notified Body Submission.

Tired of manually documenting all software requirements and tests which were changed in your latest release? No problem! Formwork analyzes what changed and create your documentation for you.

Automatic Versioning and Archiving.

You must archive your complete documentation for old versions of your medical device. Sounds like chaos? Let Formwork do it for you.


Formwork is less expensive than almost any other compliance software on the market.


599 EUR/month

(+ VAT)

Get full access to Formwork for unlimited users and one Medical Device.

  • Unlimited user accounts!

  • Unlimited documents

  • 1 Medical Device

  • Document management system for your ISO 13485 QMS

  • Software Requirements and Test Management for IEC 62304 compliance

  • Risk Management based on ISO 14971

  • Usability data tracking based on IEC 62366

  • FDA Title 21 CFR Part 11 compliant and ISO 13485 validated


? EUR/month

(+ VAT)

Nope. We're not selling Formwork to enterprises. Our mission is to help startups. In our experience, large enterprises come up with weird feature requests which would make Formwork big, bloated and unusable for startups. And that would suck! Because startups are the ones who get stuff done.

Frequently Asked Questions

Is Formwork stable or some sort of beta software?

Formwork is stable and well-tested. We actually use it for maintaining our own QMS and Technical Documentation of a Medical Device we've brought to market! That started in 2020. Since 2021, we've been onboarding customers to Formwork. Our customers are medical device manufacturers and use it for running their QMS and doing their technical documentation - some of them are shown at the top of this page.

What sort of medical device manufacturers use Formwork?

Mostly class I manufacturers and some class IIa/b manufacturers.

Can we export all our data?

Yep! You can export everything as PDF or markdown files.

How hard is it to migrate to another compliance software if we change our mind?

Not too hard, but definitely some work - but probably much easier than when using other software. We offer a full data export in the format of PDF or markdown files. While there still will be some effort on your side when migrating to another system (mostly copy-pasting of documents), the fact that we offer a full data export in machine-readable (markdown) files makes it much easier to migrate away from our system than those of other vendors.

Has Formwork passed audits?

Nope. That's because most of our customers are class I manufacturers and the class IIa/b manufacturers are currently preparing their Notified Body audits. We think Formwork will easily pass QMS / Techdoc audits, but, of course, we can only say that for sure once it has happened. Until then, we provide full and free support for Formwork customers going through audits.

Can we use Formwork for a hardware device?

Probably, but not sure. Formwork is geared towards manufacturers of software as a medical device (SaMD). We don't have much experience with hardware. That being said, we've talked to multiple hardware manufacturers and it seems very likely that Formwork offers pretty much all features you need, e.g. document management, requirements management, risk management and traceability.

Why is Formwork less expensive than other compliance software?

Other manufacturers have become lazy and bloated. They're used to charging outsized prices for software which doesn't deliver much value. They argue that certain properties of their software ("it's validated!") make it worth the high price. That's just not true. Our pricing is simple, fair, and lets us pay our salaries while providing you with all the support you need to pass your audit.

Regarding ISO 13485 validation of Formwork - do you provide a report?

Yes, we'll provide you with a validation report which you can use for documentation of your QMS software validation.

Does that ISO 13485 validation report cost extra?

Nope, it's included your monthly Formwork price. Other vendors like to charge for this but that's shady.

Unlimited users? For real?

Yep! We've seen that the per-seat-pricing-model of other compliance softwares simply doesn't work. Companies start sharing logins and everything becomes chaotic. That's why we encourage you to invite all your co-workers to Formwork because many features (like training) are based on having your entire company here.

Do we have to purchase user training from you at an extra cost?

Nope, Formwork is self-explanatory, no training needed! Other vendors might encourage you to purchase expensive training sessions with them because their software is crappy and nobody understands it. Don't do this. Still, if you have any questions or would like to see how we use Formwork, schedule a call any time, it's free!

Are you interested to see Formwork in action?

Let me show you how we run our own QMS in Formwork.

Schedule a Demo
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