What Do You Need To Do? Looking At IEC 62304 And Other Docs
Dr. Oliver Eidel
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Starter Course
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Updated May 19, 2024
Next, let's look at what the hell "medical device documentation" actually includes. I'll walk you through our templates and give you some examples of how you would fill them out.
Things I cover:
Things I cover:
- ISO 13485 templates for quality management system documentation
- IEC 62304 templates for software documentation
- ISO 14971 templates for risk management documentation
- IEC 62366 templates for usability documentation
- Clinical evaluation templates for, you guessed it, clinical evaluation documentation
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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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