Preparing the Usability Evaluation Protocol for IEC 62366 (Medical Device Compliance)
Dr. Oliver Eidel
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Clinical Evaluation
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Published May 08, 2021
We need to prepare before we get into the most important part, the User Test for our Summative Evaluation.
We need a list of tasks with instructions and acceptance criteria before heading into our user test!
We'll learn:
- How to "convert" the List of Hazard-Related Use Scenarios to tests in the Usability Evaluation Protocol.
- How to avoid the most common problem: Writing Software System Tests.
- How to come up with useful instructions and acceptance criteria.
- How many tests to have for each Hazard-Related Use Scenario.
And finally, here's the link to our template:
https://openregulatory.com/usability-evaluation-protocol-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/
We need a list of tasks with instructions and acceptance criteria before heading into our user test!
We'll learn:
- How to "convert" the List of Hazard-Related Use Scenarios to tests in the Usability Evaluation Protocol.
- How to avoid the most common problem: Writing Software System Tests.
- How to come up with useful instructions and acceptance criteria.
- How many tests to have for each Hazard-Related Use Scenario.
And finally, here's the link to our template:
https://openregulatory.com/usability-evaluation-protocol-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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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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