Formwork

Get your EU MDR or FDA medical device certified faster.
Automatically create documentation your auditors will love.
With Formwork. The best eQMS software for startups.

Watch The Quick Walkthrough

We're collaborating with BerlinCert, a Notified Body focused on Software as a Medical Device (SaMD), on data formats for audit submissions.
Learn more here.

What is it?

Formwork is a cloud-based, GDPR-compliant eQMS software for medical device startups. Document review, versioning and archiving. Training and CAPA management. Technical documentation for your medical device. Risk management and usability data tracking. All you need to pass your audits, in one place.

OK, what's the catch?

There is no catch. We’re just a bunch of people who are tired of shady practices in the eQMS software space and medical compliance in general. We built Formwork to help startups like yours get their medical devices certified while being transparent and fair. We’re not here to lock you in or charge you a fortune for adding more than two users.

Take a closer look

Use our templates and text editor to create your documents. Review and sign them with our built-in workflow.
User-friendly way to manage the technical documentation for your medical device. Software or hardware, we support both!
Instant feedback of the sanity of your technical documentation.

People pass audits with Formwork

Yes, we have customers who have successfully got their QMS and MDR certification with Formwork. You could be next!
“With Formwork, we successfully set up our quality management system and also used it to create the technical documentation for our class IIa medical device. We were particularly helped by the numberous explanatory videos and the easily usable templates.”
Oliver Weiss
Founder & CEO at Noah Labs
“One key aspect that stands out is the simplicity and user-friendliness of the interface and the added convenience of pre-built templates and the Wizard, which supported us in establishing an ISO 13485 compliant and certified QMS.”
Isabella Bauer
Quality & Regulatory Affairs Manager at Akina Ltd
And not just that! We have more than 2000 companies using Formwork. Here are some of our favorite customers:

Pricing

What? Are you going to tell me the price right away? Without having to talk to a random sales dude?
Damn, of course. And there’s more: we don’t do annual prices. You can cancel any time. No commitment, no strings attached.
Community Edition
Free
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
Register Now
FORMWORK STARTER
49€
/ month
(+ VAT)
Unlimited users,
billed monthly!
Special offer for early-stage startups without funding (see below). All the features of Formwork QMS + Techdoc (yes, seriously!) at a reduced price while you're getting your startup off the ground.
Unlimited user accounts!
Unlimited documents
Document management system for your ISO 13485 QMS
Review Workflow
Document Versioning
FDA Title 21 CFR Part 11 compliant
Automated QMS User Training and Documentation
Batch Export of Documents and Records
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
Apply Now
FORMWORK QMS + Techdoc
499€
/ month
(+ VAT)
Unlimited users,
billed monthly!
Startup discount, list price 799€. 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
Automated QMS User Training and Documentation
Batch Export of Documents and Records
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
ISO 13485 Validation Report
Awesome technical customer support by consultants & engineers
Register Now

How do I qualify for Formwork Starter?

You qualify for it if you're a very early-stage startup. The criteria is: No revenue, no funding (private or public) and three or less full-time people at your company, regardless of salary. In other words, you're 1-3 dudes or dudesses sitting in a garage while bootstrapping your startup (mad props, by the way). Contact us if you're interested.

QMS + Techdoc is still a lot of money.

Yes! And for this package, too, we're happy to give you a discount if you’re an early-stage startup (even if you might have some funding). Instead of the list price of 799€, you’ll pay 499€ per month. Just reach out to us and we’ll set you up with the discount. In exchange, we’re allowed to put your logo on our website, we’ll ping you for feedback on early Formwork features, and maybe you’ll write a testimonial for our website here in the future.

But I have no clue on how to set up a QMS?

We’ve got you covered! You can combine our templates with the magic of ChatGPT to create the first draft of your QMS in just a few minutes. Try it for yourself!

Frequently Asked Questions

  • Has Formwork passed audits?

    Yes! Some of our customers have successfully got their QMS and MDR certification with Formwork. You can read their testimonials here. Maybe someday we can add your success story here, too!

  • What sort of medical device manufacturers use Formwork?

    Formwork users include manufacturers targeting EU MDR compliance as well as some (much less) companies going for FDA compliance. Looking at the EU MDR companies, they either go for class I, IIa or IIb approval. Class I is the most common. To our knowledge, we haven’t seen a company use it for a class III device… yet!

  • Can we use Formwork for a hardware device?

    Yes! Formwork works for both software and hardware medical devices.

  • Can we export all our data?

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

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

    Yes, Formwork is cloud-based. The data is located in France (and Germany for redundancy). We use French and German hosting providers. We don’t use US-based cloud providers like Amazon, Google and Microsoft, due to GDPR concerns.

  • How does OpenRegulatory keep my data in Formwork safe?

    We save all our data redundantly on multiple servers: Our SQL servers are mirrored and our object storage is, too. Check out the link below for all the technical details.

  • 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.

  • 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?

    If you’re a paying Formwork customer, i.e. not using the free version: Yes, we’ll provide you with a validation report which you can use for documentation of your QMS software validation. Best of all, we provide you with that report for free, in contrast to all other shady vendors out there who like to charge you extra for sending you a PDF document.

Still Have Questions?

We're happy to talk! Reach out any time by clicking the button below :)
Formwork
499€/month
49€/month for early-stage startups
Everything you need.
Bring your medical device to market much faster than with Jira, Google Drive or Sharepoint
Create exactly the PDFs and spreadsheets which your auditors expect
Enthusiastic customer support if you get stuck during your audit
Compliance with all medical device standards: ISO 13485, 14971, IEC 62304 & 62366
The best eQMS for startups.
Unlimited users at the same price.
No lock-in: Export your data any time.
Cancel monthly.
Review all of the FAQs prior to purchase.
If anything isn't clear, just reach out.