Updated July 26, 2022
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.
On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.
Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!
If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.
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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, just send me an email.