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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

Technical Documentation

Technical Documentation is about describing which features your software has, which risks those features include, and how you do your testing. You also have to do usability (user) testing.

QMS Software

What the hell is QMS software, and do you need it? And how do you learn more about QMS software without falling asleep or being bombarded by sales calls from shady enterprise QMS vendors? Difficult questions indeed.


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.

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Case Studies

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?


Discussions about Ruby on Rails, software development and other engineering topics.
No QMS on this planet will save you from creating crappy software.