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 Report: Literature Search - SaMD
Clinical Evaluation Report: Literature Search for Software as a Medical Device You managed to identify risks, the software requirements are defined and...
Clinical Evaluation: How to Write a Regulatory Compliant Literature Review
A clinical evaluation is required for all medical devices according to the MDR. The main task of a clinical evaluation is to identify pertinent data in...
Clinical Evaluation Report (CER) For Medical Devices: 3 Easy Steps
When certifying software as a medical device (or any medical device, really), you need a Clinical Evaluation. If I had to sum it up in one sentence, the...