The affordable eQMS for medical device teams.

Yes! It depends what you mean by that though. If e.g. your 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 –

We offered demo calls in the past, but but have temporarily stopped them due to high demand. The good news is that you can simply do a self-guided demo with exactly the same content! Watch the Formwork video at the top of this page for a demo, and sign up for a free Formwork account to try everything out by yourself.

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.

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

Yes – we've got you covered for the IVDR, too! Formwork fully supports the requirements management, test case management, risk and usability management for IVDR devices.

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!

Yes. Multiple of our customers have passed FDA audits with Formwork.

Yes. At least one of our customers has passed a Health Canada audit with Formwork.

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

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.

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.

We save all our data redundantly on multiple servers: Our SQL servers are mirrored and our object storage is, too.

No. That's because the free Community Edition has usage limitations, e.g. storing up to 10 documents. Pretty much any medical device QMS documentation will contain more than 10 documents. So the free tier is perfect to get you started, but you'll need to upgrade to e.g. Formwork Starter (99€ / month) to complete the first draft of your medical device documentation.

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.

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.

Yes, you could do that (in theory)! However, 99% of people decide against this as you need to show Formwork to your auditors on an ongoing basis, and there's a lot of day-to-day compliance data you need to work on in Formwork (trainings etc.) - in any case, you'd need to move to another tool, and that other tool is likely going to cost you more time and money than Formwork.

If you're a paying Formwork customer in the 499€ / month tier: 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!

Yes. There are two big reasons for this: OpenRegulatory has been profitable from the start, and the company is still 100% owned by Oliver, so there are no external (venture capital) investors which could force us to e.g. sell the company.

This is in huge contrast to most other eQMS software companies on the market: Qualio and Greenlight Guru are funded by venture capital investors, and Matrix Requirements recently got sold to a private equity fund. None of these things are bad by themselves, but it goes to show that founders in these situations tend to have (much) less control over their companies because they no longer own 100% of them.