Clinical Evaluation
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.
Clinical Evaluation Templates
All Clinical Evaluation Articles
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Clinical Evaluation Report (CER) For Medical Devices: 3 Easy Steps
Clinical Evaluation: How to Write a Regulatory Compliant Literature Review
Clinical Evaluation Plan
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Dr. Oliver Eidel
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!