Articles Technical Documentation
Updated November 22, 2022
Dr. Oliver Eidel
The IEC 62304 describes how to develop and document software for medical devices. This page contains all our articles we’ve posted so far on this standard, plus questions we’ve been asked by our consulting clients. Additionally, we publish our IEC 62304 templates for free (yes, seriously) and you can also find those below.
We’ve published all our IEC 62304 templates for free, no strings attached! Take a look :)
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.
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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!