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.

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! You can export everything as PDF or markdown files.

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.

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.

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.

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.

It depends what you define as "audit". To our knowledge, Formwork has successfully passed at least three competent authority audits of MDD / MDR class I manufacturers. Regarding MDR class IIa/b, we have a few companies which already have used Formwork to create, generate and submit their documentation to their Notified Body. But right now, all of them are stuck in the waiting queue because the MDR is still a fiasco. So, right now, we unfortunately can't claim a company with a class IIa/b to have passed an audit with Formwork, simply because none of their Notified Bodies have even started to look at their documentation (crazy)! If you're unsure whether you'll pass your audit with Formwork, reach out to us and we'll provide full and free support for you going through your audit.

Probably, but it's a bit of a hack right now. 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. The core idea here is to "misuse" some of the Formwork sections for hardware stuff instead, e.g. you'd use the Softare Requirements section for hardware requirements, too. Not very elegant, I agree. We're working on better hardware support.

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.

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.

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.

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!

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.

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.