Actually Getting The Standard (IEC 62304 Course Episode 2)

Dr. Oliver Eidel · IEC 62304: Medical Device Software Development · Updated November 26, 2025
00:00 Trying to purchase the standard again
00:45 Taking a first look
03:13 Why you need templates (use our free ones)
06:50 The mapping table

In this episode, I try (again) to purchase and download the IEC 62304 standard, which is a PDF file. After succeeding, I show you what it's all about and how medical device compliance roughly works.

We'll look at why you need templates (ugh) and how you can use our free templates to save lots of time and money (nice) :)

Check out our website https://openregulatory.com for more!
Dr. Oliver Eidel

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!
More about me

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