Regulatory software, Re-imagined.

Join 320+ companies which ship software faster.
With Formwork.

Formwork is used by Healthcare startups to ship medical device software faster.

OpenRegulatory has truly been a game-changer for us. As a startup with limited resources, we had zero experience in regulatory compliance. But with OpenRegulatory's help, we not only got up to speed on the requirements but also learned so much about the processes that it became part of our daily practice and made us better developers.

Their Formwork software is a lifesaver - it covers almost the regulatory requirements for our FDA class II device in a structured and efficient way. Plus, it's user-friendly, cost-effective, and always open to feedback and suggestions from their customers.

The team at OpenRegulatory is a pleasure to work with - always available to support you, answer questions, and review your documents. If you need a little extra guidance, their Wizard tool provides easy-to-understand videos that break down the complex standards and regulatory language into actionable steps. So, you can sit back and relax, knowing that you have a top-notch compliance solution in your corner.

In short, OpenRegulatory transforms the normally complex and confusing process of regulatory compliance into a pragmatic, workable approach. We couldn't be happier with our experience and highly recommend them to anyone in the medical device industry.

George Michalopoulos

CEO at iCat Solutions Ltd

GDPR Compliance

Formwork is fully GDPR-compliant

Contrary to shady US-based enterprise eQMS software vendors, we host data in the EU with EU-based companies (no, not AWS - real EU companies, incorporated and located in the EU).

This means that it's much easier for you to be GDPR-compliant if you're storing personal health data in your QMS.


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 Community Edition

Best of all: It's free

Yup, you heard right.

We've decided to make Formwork available for free, as Formwork Community Edition!

This is the best way right now to get your Quality Management System started, period. It's cheaper than anything out there (have you ever seen free regulatory software before?) and much better and compliant than Google Drive, Confluence and GitHub or GitLab.

No strings attached.

This is part of our commitment to help Healthcare startups enter the market.

And if you ever need more features to further automate your painful regulatory work, you can always upgrade to Formwork Pro at any time.


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

Community Edition


Perfect if you want to get started and are on a budget! Better than Confluence and GDrive. Set up your free, ISO 13485 - compliant Quality Management System. Also includes FDA compliant e-signatures.

  • Unlimited user accounts!

  • Unlimited documents

  • Document management system for your ISO 13485 QMS

  • Review Workflow

  • Document Versioning

  • FDA Title 21 CFR Part 11 compliant

Formwork Plus


(+ VAT)

Use our video section with its bulletproof step-by-step courses to get all your documentation done. Batch export all of your QMS documents for your audit. Train users automatically on your SOPs.

  • Unlimited user accounts!

  • Unlimited documents

  • Document management system for your ISO 13485 QMS

  • Review Workflow

  • Document Versioning

  • FDA Title 21 CFR Part 11 compliant

  • OpenRegulatory Video Screencasts

  • Automated QMS User Training and Documentation

  • Batch Export of Documents and Records

  • ISO 13485 Validation Report

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Formwork Pro


(+ VAT)

Absolutely everything you need to automate your painful regulatory work. Keep track of requirements, risk management and usability tests. Auto-generate technical documentation for your devices.

  • Unlimited user accounts!

  • Unlimited documents

  • Document management system for your ISO 13485 QMS

  • Review Workflow

  • Document Versioning

  • FDA Title 21 CFR Part 11 compliant

  • OpenRegulatory Video Screencasts

  • Automated QMS User Training and Documentation

  • Batch Export of Documents and Records

  • ISO 13485 Validation Report

  • Technical Documentation for Medical Devices

  • Software Requirements and Test Management for IEC 62304 compliance

  • Risk Management based on ISO 14971

  • Usability data tracking based on IEC 62366

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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.

Is Formwork is cloud-based tool? Where is the data located?

Yes, Formwork is cloud-based. The data is located in France. We use French hosting providers. We don't use US-based cloud providers like Amazon, Google and Microsoft, due to GDPR concerns.

Can we pass an ISO 13485 audit with the free Formwork Community Edition?

Yes, totally! All the document control features (like reviewing and signing documents) are included in the free Community Edition. However, the Pro version will make your life a lot easier: You can Batch Export all your documents in one go (auditors probably want you to export everything as PDFs), and we provide you with a ISO 13485 - compliant software validation report. In the free version, you have to create this validation report yourself. Also, the Pro version has some additional features which make 13485 compliance even easier, like user training.

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!

Do you offer an enterprise version with enterprise pricing?

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. That would suck! Because startups are the ones who get stuff done.

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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