Get your EU MDR or FDA medical device certified faster.
Create documentation your auditors will love.
With
Formwork
, the eQMS by OpenRegulatory.

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!
You get instant feedback regarding th completeness of your technical documentation.

From Zero To Successful Audit.
In 6 Months.

akina, a startup focusing on Physiotherapy, passed their MDR QMS audit only 6 months after starting with Formwork:
"OpenRegulatory's Formwork offers distinct advantages to startups embarking on their regulatory compliance journey. With its dual functionality encompassing both Quality Management System (QMS) and Technical Documentation capabilities, it has provided us with a holistic solution that streamlines our quality processes while enhancing the management of our technical documentation.

One key aspect that stands out is the simplicity and user-friendliness of the interface and the added convenience of pre-built templates and a wizard tool, complemented by instructive tutorial videos, which supported us in establishing an ISO 13485 compliant and certified QMS. Another standout aspect of OpenRegulatory is their exceptional customer support. The team consistently demonstrates a commitment to addressing our inquiries promptly and providing assistance as needed. Their dedication to ensuring our satisfaction is truly commendable and makes us feel valued as customers.

In conclusion, OpenRegulatory has proven to be an invaluable partner for startups embarking on their regulatory compliance journey."
Isabella Bauer
Quality & Regulatory Affairs Manager at Akina Ltd
Noah Labs got their connected-care platform for cardiology certified as an MDR class IIa device:
“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 numerous explanatory videos and the easily usable templates.”
Oliver Weiss
Founder & CEO at Noah Labs
And Darrel Francis, Professor of Cardiology at Imperial College London, is a huge fan of Formwork, too:
"OpenRegulatory was the ONLY site that had anything actually USEFUL on it! Every other site was just companies saying how brilliant their software is, but (as Oliver points out) mysteriously no actual screenshots.

Then we thought "Free stuff! That's amazing! Let's get it and try and do it ourselves."

Then we read it and said, "Hang on, this regulatory stuff is actually quite straightforward when someone who actually DEVELOPS stuff, is explaining it to you, because they don't make up bullshit terms to confuse you."

Then we said, "OK how much is the paid version?"

And we worked out that we didn't actually need the paid version yet, but wanted to give something back to the company, signed up for it. The meetings with Oliver were absolutely brilliant. He cut through complex questions like a knife through butter.

Amazing. And he gave lots of excellent free advice."
Prof. Darrel Francis
Professor of Cardiology at National Heart and Lung Institute, Imperial College London
And not just that! We have more than 2000 companies using Formwork. Here are some of our favorite customers:

Pricing & Features

Formwork Community Edition
Free forever and perfect for you to get started. Better than Google Drive, Jira and Sharepoint.
Formwork Starter
All features of our most expensive tier (right side), at a much lower price as long as your company doesn't have funding (see below).
Formwork QMS + Techdoc
Absolutely everything your company needs for your medical device compliance. 499€ if we can show your logo here, otherwise 799€ (see below).
Price
Free!
49€ / month
Early-stage startup discount
499€ / month
Startup discount
User Seats
Unlimited!
Unlimited!
Unlimited!
Documents
Unlimited!
Unlimited!
Unlimited!
Up- / Downgrade, Cancellation
Switch any time (monthly)
Switch any time (monthly)
We won't delete your data if you downgrade
Switch any time (monthly)
We won't delete your data if you downgrade
ISO 13485 Document Management
FDA 21 CFR Part 11 e-signatures
IEC 62304 Requirements & Test Management
ISO 14971 Risk Management
IEC 62366 Usability Management
Automated User Trainings & Quizzes
Export all data & generate audit spreadsheets
ISO 13485 Validation Report
Enthusiastic Customer & Audit Support

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! Customers have passed MDR audits with Formwork. You can read their testimonials above. Will your company be next?

  • Do you provide "audit support"?

    Yes! It depends what you mean by that though. If e.g. you auditor has technical questions about Formwork, we’ll be happy to answer those and provide you with explanations which have helped other customers pass audits successfully.

    If you need an additional feature which you consider important for your audit, we’ll be happy to look into it. We’ve already built many such features for other customers, but we can’t guarantee we’ll build everything.

    We don’t provide consulting though – 

  • Can I schedule a call for a demo?

    We usually don’t do demos because we believe in transparency and try to provide everything you might be interested in on our website, here, for free! Watch the video above for a Formwork demo, and create your own Formwork account right away and try out the free trial. If you have further questions, send us an email by clicking the “send us an email” button above.

  • Does Formwork integrate with Jira, Confluence, etc.?

    No. As consultants, we’ve helped 150+ companies with their medical device compliance, and, when looking closely, we’ve never found a reasonable use case for an eQMS integration with Jira or any other development tool. Please read this article for more context on our decision.

  • How do I qualify for the early-stage startup discount (49€ / month)?

    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 – click the link below the pricing table.

  • How do I qualify for the normal startup discount (499€ / month)?

    You qualify for the normal startup discount if we can show your company logo on our website and ping you for a testimonial later.

  • Does Formwork support hardware devices?

    Yes – we’ve got you covered. Formwork fully supports the requirements management, test case management, risk and usability management for hardware devices.

  • Which medical device classes is Formwork used for?

    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!

  • Does Formwork support FDA compliance?

    We think so. Here’s more context: The majority of our customers is currently targeting EU MDR compliance, and we have the successful audit results to prove that Formwork is suitable for EU MDR compliance. For FDA compliance, a smaller number of customers is currently using it and we’re still waiting for their audit results. We think we have all the right features, but we can’t claim (yet) that a company has passed a FDA audit with Formwork.

    Choosing Formwork for FDA compliance right now is arguably a bit riskier than other software, but then again, you can export you data any time and switch to another provider if you change your mind.

    The inverse is not true: If you choose another provider instead of Formwork, you’ll be locked in forever, both data-wise and contractually.

  • Can we export all our data?

    Yes! You can export everything as PDF, Markdown or Excel 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.

  • Can I host Formwork on my own server infrastructure?

    No, unfortunately not. We’re a small team, and offering a self-hosted option while also providing technical support at reasonable prices didn’t seem feasible to us. We only offer Formwork as cloud-hosted tool.

  • 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.

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

    Technically, yes. All the document control features (like reviewing and signing documents) are included in the free Community Edition. However, the paid 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 paid 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. You can export your data any time as PDF, Markdown or Excel files – you can start it yourself and it takes a few minutes. You’ll have to put in some work actually integrating this data into your new system, of course. Contrast this with other eQMS providers which don’t even provide a data export like we do.

  • Why is Formwork less expensive than other compliance software?

    Other manufacturers have huge sales teams. We just have our website. Other manufacturers target large enterprise companies. We target startups and fast-moving companies. Other manufacturers put a lot of effort into keeping their software secret, because it actually sucks. We believe in transparency. This and many other reasons allow us to charge much lower prices. And we love startups.

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

    If you’re a paying Formwork customer (499€ and upwards): Yes, we’ll provide you with a validation report which you can use for documentation of your QMS software validation. With this report, Formwork has been accepted by all auditors so far. Best of all, we provide you with this report free of charge while our competitors charge you huge additional fees!

Ready To Get Started?
Click the button to create your Formwork company account and start your free trial of Formwork QMS + Techdoc right away, no credit card required. You can continue to use the free version after your trial.
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Got Questions?
Reach out any time, we're happy to help!
Send us an email

Formwork

49€, 499€ or 799€ per month
Cancel any time, no commitment
Startup discounts available
Everything you need.
Proven system: Our customers have passed multiple EU MDR audits
Also used by companies preparing FDA submissions
Bring your medical device to market much faster than with Jira, Google Drive or Sharepoint
Enthusiastic customer support if you get stuck during your audit
Create exactly the PDFs and spreadsheets which your auditors expect
Compliance with all medical device standards: ISO 13485, 14971, IEC 62304 & 62366
The most transparent eQMS.
Unlimited users at no extra charge.
No lock-in: Export your data any time.
Review all of the FAQs prior to purchase.
If you have any questions, just reach out.