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.

Mostly class I manufacturers and some class IIa/b manufacturers.

Yep! 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.

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.

Nope. That's because most of our customers are class I manufacturers and the class IIa/b manufacturers are currently preparing their Notified Body audits. We think Formwork will easily pass QMS / Techdoc audits, but, of course, we can only say that for sure once it has happened. Until then, we provide full and free support for Formwork customers going through audits.

Probably, but not sure. 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.

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.

Yes, we'll provide you with a validation report which you can use for documentation of your QMS software validation.

Nope, it's included your monthly Formwork price. Other vendors like to charge for this but that's shady.

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!