Creating a List of Hazard-Related Use Scenarios for IEC 62366 (Usability For Medical Devices)
Dr. Oliver Eidel
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Clinical Evaluation
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Published May 08, 2021
Let's dive right into it and write down Hazard-Related Use Scenarios for the magic Covid Photo App.
Hazard-Related Use Scenarios are (usage) scenarios in which Hazards could arise (sounds obvious, right?).
We'll see whether we can come up with some scenarios for the magic Covid Photo App and how to document them.
We'll also learn about other core use scenarios you may have to cover for 13485 compliance.
Resources
Template: List of Hazard-Related Use Scenarios
Here's the obligatory link to our template for the List of Hazard-Related use Scenarios:
https://openregulatory.com/list-of-hazard-related-use-scenarios-template-iec-62366/
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/
Hazard-Related Use Scenarios are (usage) scenarios in which Hazards could arise (sounds obvious, right?).
We'll see whether we can come up with some scenarios for the magic Covid Photo App and how to document them.
We'll also learn about other core use scenarios you may have to cover for 13485 compliance.
Resources
Template: List of Hazard-Related Use Scenarios
Here's the obligatory link to our template for the List of Hazard-Related use Scenarios:
https://openregulatory.com/list-of-hazard-related-use-scenarios-template-iec-62366/
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/
Keep watching
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Preparing the Usability Evaluation Protocol for IEC 62366 (Medical Device Compliance)
Dr. Oliver Eidel
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Hazard-Related Use Scenarios (Risk Analysis for Medical Devices + Usability Engineering)
Dr. Oliver Eidel
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List of Hazard-Related Use Scenarios
Dr. Oliver Eidel
updated about 2 years ago
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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