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Startups Pass Audits.
With Formwork.

Choose the eQMS software which startups love and join 1.700+ companies already automating their QMS and Technical Documentation.

Used By Successful Healthcare Companies

akina icura Line Systems Molibso mucoaid my mhealth Noah Labs Onqo Pathmate Technologies Pregive

Testimonials

People Pass Audits With Formwork

akina develops Physiotherapy software for patients to reduce pain and improve mobility. Using Formwork, they received their QMS certification by DQS, a Notified Body in Germany, in August 2023. It only took them 7 months from contacting DQS to getting their certificate! Isabella is the Quality & Regulatory Affairs Manager at Akina - read what she has to say about their experience with Formwork.

“OpenRegulatory has proven to be an invaluable partner for startups like us when embarking on their regulatory compliance journey.

One key aspect that stands out is the simplicity and user-friendliness of the Formwork interface. That, along with the pre-built templates and the Wizard, supported us in establishing an ISO 13485 compliant and certified QMS. Another standout aspect of OpenRegulatory is their exceptional customer support.”

Isabella Bauer
Quality & Regulatory Affairs Manager at Akina Ltd

Noah Labs develops a Connected-Care Platform for heart patients. In November 2023, they passed their QMS audit with BerlinCert, a Notified Body in Germany.

“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

More Testimonials

...And There's More!

“OpenRegulatory's Formwork has made our regulatory lives so much easier. Everything about the tool is easy to use and the regulatory documentation prepared by the team makes the job almost fun (yes, fun). Our QMS couldn't have developed with better support. The technical documentation is straightforward, making it quick and easy to complete. What's more, the Wizard videos, tutorials and courses are super clear and educational. We've learnt a lot during the process thanks to all the available mediums. OpenRegulatory's Formwork is the best regulatory tool you can have on your way to certification.”

Anaïs Grimal
Co-Founder & CTO at Louise

“At Line Systems, we've had the privilege of partnering with OpenRegulatory for both their regulatory consulting services and, more recently, their Formwork eQMS system. The OpenRegulatory team is knowledgeable, pragmatic, and highly professional. They are attuned to customer feedback, and their swift turnaround on implementing new features is inspiring. We've witnessed consistent enhancements in Formwork, which we feel is evolving beyond just a regulatory compliance tool to a comprehensive platform for release planning and project management. With Formwork and the OpenRegulatory team behind, we are confident in achieving regulatory compliance in a seamless, practical manner, while achieving the quality and design control needed to bring our SaMD to market.”

Simon Madsen
Co-Founder & CEO at Line Systems

“OpenRegulatory has truly been a game-changer for us, a startup with limited resources and zero experience in regulatory compliance. Formwork is user-friendly and cost-effective, and the OpenRegulatory team is always open to feedback and suggestions from their customers. 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. 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

“Switching to Formwork has really made maintaining regulatory compliance feel less like busywork. In combination with the straightforward templates we only wish Formwork had been around sooner.”

Jonas Heidelbach
Chief Medical Information Officer at Onqo Health GmbH

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.

Features

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.

What makes Formwork different?

Compare Formwork with other eQMS software.

Other eQMS Software

Formwork

Shady pricing model

No public prices listed on website, only "contact us" buttons which lead to calls with shady sales dudes. Customized offers to maximize the amount of money they can take from you.

Transparent pricing model

Our prices are fair, transparent and on our website. There are no custom offers, everyone gets the same price (we do give discounts to early-stage startups though). Scroll down to see our prices and discounts.

Your data is locked in

There's no way to export your data so that you can move to another eQMS software because they want to lock you in.

Export your data any time

You can export all of your data any time with one simple click! The batch export takes a few minutes and you'll be able to take your entire QMS content and move somewhere else, if you like.

Contractual commitment of a year or longer

You sign a contract with them and have to pay for one year up front (or even longer) without being able to cancel early if you change your mind.

Monthly payments, no commitment

Formwork is billed monthly and you can cancel any time by simply clicking a button, no need to reach out to us! Also, just export your data beforehand, if you like, there's no lock-in.

Limited seats, additional seats are expensive

Your license includes a limited number of user accounts. Once your company grows, you'll have to purchase additional seats which are likely to be very expensive. Users in your company will start sharing accounts, leading to huge chaos.

Unlimited user accounts

Formwork includes unlimited user accounts - you pay one flat price for your entire company and have no hidden costs once your company grows.

Clunky text editor (or none at all)

Other eQMS software often has clunky text editors or none at all, forcing you to use Microsoft Word (ugh!) or other software for editing your documents.

Markdown-based rich text editor

We're using an open-source, markdown-based rich text editor which is easy to use and enables you to create all your documents in your browser.

Needs heavy configuration which costs more money

Other eQMS software is so generic that you need to spend lots of time on configuring it so that it's finally compliant e.g. with the ISO 13485. Often, those eQMS companies offer consulting services for this which cost you even more money.

Pre-configured and compliant out of the box

Formwork comes pre-configured and there's no additional work you have to put in to adapt it to your regulatory requirements. That's because we specifically build Formwork for startups developing software as a medical device (SaMD) - and it supports hardware, too!

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 QMS or Formwork QMS + Techdoc at any time.

Pricing

We don't have annual prices, so you don't have to commit - you only get billed per month and can cancel any time.

Community Edition

free

Billed monthly, cancel any time!

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 QMS

349€ / month (+ VAT)

Billed monthly, cancel any time!

Just like the Community Edition with advanced QMS features which help you automate even more things: Quiz-based user trainings, CAPA tracking and batch exports in just the right format you need for your audit.

  • Unlimited user accounts!

  • Unlimited documents

  • Document management system for your ISO 13485 QMS

  • Review Workflow

  • QMS Overview Export

  • Document Versioning

  • FDA Title 21 CFR Part 11 compliant

  • Automated QMS User Training and Documentation

  • Batch Export of Documents and Records

  • ISO 13485 Validation Report

Navigate to Settings - Billing to purchase.

Formwork QMS + Techdoc

799€ / month (+ VAT)

Billed monthly, cancel any time!

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

  • QMS Overview Export

  • Document Versioning

  • FDA Title 21 CFR Part 11 compliant

  • 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

Navigate to Settings - Billing to purchase.

Formwork All-Inclusive

1.999€ / month (+ VAT)

Billed monthly, cancel any time!

The ultimate package to get your medical device certification done. It combines all Formwork functionalities with free consulting: Document reviews, Q&A with our consultants and us joining your audits until your certification is complete.

  • Unlimited user accounts!

  • Unlimited documents

  • Document management system for your ISO 13485 QMS

  • Review Workflow

  • QMS Overview Export

  • Document Versioning

  • FDA Title 21 CFR Part 11 compliant

  • 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

  • Includes Wizard Video Course (2.999€ value)

  • Premium Support

  • Consulting Included!

New model - we're looking for clients to test this.

Formwork Pilot Customers

Need a Discount?

If you're looking at Formwork QMS + Techdoc, you're also looking at 799€ per month. While that's probably still cheaper than what others ask for, it's still a lot of money!

If you're an early-stage startup and haven't raised huge amounts of money yet, we're happy to give you a discount. And just like our prices, our discount is also public, transparent and simple: Instead of 799€, you pay 499€ per month. In exchange, we're allowed to put your logo on our website (as, you guessed it, a Formwork customer), we'll ping you for feedback on early Formwork features, and maybe you'll write a testimonial for our website here in the future.

We call that being a Formwork Pilot Customer. If you're interested, reach out by clicking the link below!

Frequently Asked Questions

Is Formwork stable or some sort of beta software?

Formwork is stable and well-tested. In fact, multiple companies have certified their QMS using Formwork! Actually, we have been using it ourselves since 2020 for maintaining our own QMS and Technical Documentation of a Medical Device we've brought to market. In 2021, we started onboarding other companies (now more than 1800!) and using their feedback to keep improving Formwork every day.

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 export all our data?

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

Learn more
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.

Learn more
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?

Yes! Some of our customers have successfully got their QMS certified with Formwork. You can read their testimonials at the top of the page. Maybe someday we can add your success story here, too!

Learn more
Can we use Formwork for a hardware device?

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

Learn more
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.

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.

Learn more
Do you offer other enterprise features, e.g. a locally-hosted version, more customization, and shady pricing?

Nope, nope and nope. Formwork is geared towards startups with the goal of having great features without lengthy customization while being easy to use and affordable. It's also easy to "try before you buy"! See for yourself if it works for you and purchase it if you like it. If you need something which is hugely different, e.g. more customization options or a locally-hosted version, it's likely that we've already thought about that and decided against it because we're a small team and want to build Formwork for other small teams. You might want to look at shady enterprise eQMS software instead.

Learn more

Ready to see Formwork in action?

Schedule a demo with me to see how we run our own QMS in Formwork.

Try it yourself
No QMS on this planet will save you from creating crappy software.