Updated August 3, 2022
Dr. Oliver Eidel
In simple terms, your Clinical Evaluation is a rather lengthy document which looks a lot like a Bachelor’s thesis (yup). Its main goal is to show that your software will be effective and that its risks are acceptable.
The best news is that we’ve published all our Clinical Evaluation templates for free! Check them out below.
Also note that we have many more templates besides the ones for Clinical Evaluation - head over to our templates page for more templates.
On a slightly different note: Did you know that we also provide consulting, often guiding startups from start to finish in their medical device compliance?
And there's so much more: If you're looking for the best QMS software ever, look no further. We've built Formwork, and it's free!
If you're interested in watching me write documentation for a medical device, check out our screencasts. And finally, there's our free Slack community with 500+ people from medical device companies in which people help each other out by answering questions. You should check it out! :)
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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.