How Does The IEC 62304 V-Model Work For Software Development Of Medical Devices?
Dr. Oliver Eidel
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Clinical Evaluation
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Published July 26, 2023
When you develop software as a medical device (SaMD), you have to develop and document it in a so-called IEC 62304 - compliant way. The IEC 62304 is a very lengthy PDF which, among other things, comes up with something called a "V-Model" for documenting software.
So, what the hell is this V-Model? How does it compare to waterfall and agile development?
This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information:
https://openregulatory.com/courses/the-wizard/
So, what the hell is this V-Model? How does it compare to waterfall and agile development?
This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information:
https://openregulatory.com/courses/the-wizard/
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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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