Getting Started

If you have absolutely no clue about medical devices and where to start, this is the place to get your started! You’ll learn about coming up with the right classification for your medical device, writing your intended use, accessing standards for little money, and many other exciting things.

Quality Management

Quality Management is all about, um, ensuring quality in your company. If that sounds weird, you’re not alone! Hopefully our articles can help.

Technical Documentation

QMS Software

This post is a summary of all our content on Quality Managemenet System (QMS) software. My assumption here is that you are completely clueless and have no idea what QMS software is - but no worries, we’ve got you covered! After reading all articles below, you’ll have a solid idea of what QMS software is and whether you need it.


You might think your regulatory questions are unique to your situation, but chances are that other startups have already asked us. We publish all commonly-asked questions here.

Still lost in regulation?

Reach out and get help!

Send us an email

Case Studies

Case studies of our clients. These are typically stories how startups get their software certified for very little money in very little time.

Consultant Failures

Anonymized stories of startups dealing with other consultants. These are typically stories how startups don’t get their software certified and lose a ton of money, often six-digit sums.


Formwork Feature Focus

Formwork is our eQMS software. Used by 150+ companies, optimized for startups and fine-tuned for easy usability. Even my mom could understand it! Best of all, it has a free Community Edition. In Formwork Feature Focus, we go through interesting Formwork features.

Regulatory News

Regulatory news and other exciting things happening in the regulatory world. Generally speaking, most updates here are about how your life is about to get more complicated and you’ll be writing even more documentation. But there are some much-appreciated exceptions!


The OpenRegulatory Blog. If you’ve scrolled down this far, you’re probably bored with all the other regulatory articles above and are just searching for entertainment. Maybe our blog can help you there?

Digital Health Jobs No Cookie For You Privacy Policy Imprint
No QMS on this planet will save you from creating crappy software.