Free IEC 62304 Course: Documenting Software as a Medical Device (SaMD)
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Updated November 26, 2025
00:00 Introduction
01:15 Getting the standard at evs.ee
04:34 Getting stuck
Our awesome new IEC 62304 course! Learn how to document your software as a medical device (SaMD) in a compliant way to get certified as per the EU MDR.
The IEC 62304 is the standard for software as a medical device, and following it is one of the biggest chunks of work when it comes to bringing a software medical device to market.
We've updated the entire course in 2025 and re-recorded every video. Enjoy!
Head over to https://openregulatory.com for free EU MDR templates and our awesome eQMS software :)
01:15 Getting the standard at evs.ee
04:34 Getting stuck
Our awesome new IEC 62304 course! Learn how to document your software as a medical device (SaMD) in a compliant way to get certified as per the EU MDR.
The IEC 62304 is the standard for software as a medical device, and following it is one of the biggest chunks of work when it comes to bringing a software medical device to market.
We've updated the entire course in 2025 and re-recorded every video. Enjoy!
Head over to https://openregulatory.com for free EU MDR templates and our awesome eQMS software :)
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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!
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!
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