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September 22, 2023

Review of OpenRegulatory Formwork as QMS Software

Dr. Oliver Eidel

Key Facts about Formwork as QMS Software


QMS Features

Yes, this is a specialized QMS software which contains QMS-specific features like electronic document signing and document versioning.

Requirements Management

Yes, this is specialized requirements management software which enables you to manage your regulatory requirements in a compliant way.


Free trial

Yes, you can try this software out for free!

Data exportable

Yes, you can export your data in a structured way at any time.

Text editor

Yes, this software has its own text editor, that means you can create and edit documents directly in the software.


Yes, this software has a cloud-hosted option.


No, this software does not have a self-hosted option.


Pricing model

Free, 349€ or 799€ / month, unlimited users

Typical price

499€ / month (startup discount, unlimited users)

Minimum commitment

1 month


Company ownership

100% Founder-owned

Company profitability

Yes, this company is profitable.

Formwork is our own software, so, brace for impact, this review might be biased.

Still, let me try to be objective here: Our goal for Formwork was to be different. We looked at other QMS software on the market and tried to improve upon all those things which made them so terrible. Our most important goals were:

No lock-in, export your data any time. You can literally push a button and export your data any time in a structured format. That means you can move to another QMS software any time if you’re unhappy. This is in huge contrast to other providers who try hard to lock you in. They also try to lock you in by committing to their software for months or even years (see next section).

No commitments, monthly payments. You pay monthly via credit card and can cancel any time. Contrast this with other QMS software providers which lock you in for at least 12 months, if not multiple years. How is that okay?

Unlimited users, flat fee, transparent pricing. You only pay one flat fee per month - the one listed on our website. The price includes unlimited user accounts, so you won’t pay any additional fees if your company grows. Our competitors, again, try to scale up their pricing dramatically once your company is going to grow.

Compliant out of the box. There’s no setup needed. Formwork is set up out of the box to be compliant with ISO 13485, IEC 62304, ISO 14971 and IEC 62366. You won’t lose precious time getting started. Just create your account and start writing documentation.

Try before you buy: We offer free trials of the paid versions of Formwork. Just reach out! Most of our competitors don’t allow you to try out their software (crazy, right?) and assume you’ll purchase based on sales demos and videos they send you - insane.

Check out the Formwork page for more information! :)

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

Congratulations! You read this far.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you're still lost and have further questions, reach out any time!

No QMS on this planet will save you from creating crappy software.