Updated March 16, 2023
Dr. Oliver Eidel
The performance evaluation is a requirement for IVD software under the IVDR (formerly the IVDD). It’s somewhat similar to the clinical evaluation for medical devices, but focused less on clinical data and more on (you guessed it) performance.
The best news is that we’ve published all our Performance Evaluation templates for free! Check them out below.
Also note that we have many more templates besides the ones for Performance Evaluation - head over to our templates page for more templates.
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I'm a medical doctor, software engineer and regulatory dude. I've helped 50+ companies with their medical device compliance. I mainly work as a regulatory consultant, but my goal is to make consulting unnecessary by publishing all of our articles and templates for free :)
If you're still lost and have further questions, just send me an email. Read more about me here.