Yes! Some of our customers have successfully got their QMS and MDR certification with Formwork. You can read their testimonials here. Maybe someday we can add your success story here, too!

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! Formwork works for both software and hardware medical devices.

Yes! You can export everything as PDF or markdown 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.

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.

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.