What Do You Need To Do? Looking At IEC 62304 And Other Docs
Dr. Oliver Eidel
•
Starter Course
•
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
On a different note: Do you need any help with your EU MDR efforts?
We’ve worked with 100+ companies and helped them certify their devices in weeks, not months. Talk to us now – first calls are free! Check out our services and prices here.
Or, if you don’t like talking to humans, check out our Wizard. It’s a foolproof, step-by-step video course for getting your compliance done yourself.
And if you’re looking for the best QMS software for lean, founder-led companies, check out Formwork. It automates your compliance, and there’s even a free version for you to try out!
0 comments
No comments yet. Be the first one to share your thoughts!
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!
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!