Quality Management 1 answer

Is it Formwork useful if not yet made a spin-out?

Anonymous · Published December 09, 2025
Hi.

We are a team at an institution working trying to develop a SaMD. We haven't spinned-out yet, if we achieve to do it somewhere in the following years. 

A colleague recently sent me the article about releasing the MDR roadmap, and my head exploded. Wow. Thanks a lot. Thanks also for all the templates and the context links. 

Then I came to think about Formwork. The Roadmap steps and Formwokr seems to be made for start-ups or spin-outs. What about starting before spinning-out? Can we start with the community edition? What about if we finally spin-out. Can we migrate accounts to the new SME?

Any help will be appreciated. 

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1 Answer

Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
Hey, thanks for your great question and for your kind words regarding our roadmap, much appreciated! :)

The good news is that, yes, we actually have quite some experience with spin-offs (e.g. out of Universities) and it's actually quite simple!
 
The easiest solution would be to simply create your company account with the Community Edition right now and get started. The question is - what will change once you're spun out of your institution. In our experience, often it's only the company name which changes, and the cool thing is that you can simply change that in the Formwork settings. This will automatically update your company name across all your PDF documents and records, so there's pretty much zero work for you there.

Besides that.. maybe you might want to change some of your processes (SOPs) once you're spun out, depending on whether your institution forced you to use their processes while you were still not spun out. But then again, that's only hypothetical, best case, you use our free templates from the start as they're quite lean and save you lots of time.

Besides this, there are also more complex setups which we offer - as an example, we do offer custom packages for institutions where they pay us a monthly fee and all their startups (!) get upgraded to Formwork QMS + Techdoc, our 499€ / month package. But.. that might really be overkill here.

So yeah, I'd say, just get started with the Community Edition and take it from there :) let us know if you have any further questions!

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