Category: European Commission

How to perform a clinical evaluation of medical devices – Part 3 – Suggested Table of Contents for the Clinical Evaluation Report – CER

Observation 1 – This is the third installment of my series on medical device clinical evaluation. I suggest reading the first part at (http://www.medicaldevice.expert/) to have a better understanding of the concepts so the understanding of this part is easier). The Clinical Evaluation Report – CER is the document which contains the results of the […]

How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means

This is the second installment of my series on medical device clinical evaluation. I suggest reading the first part (How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities – http://www.medicaldevice.expert/europe/european-commission/medical-device-regulation/how-to-perform-a-clinical-evaluation-of-medical-devices-part-1-overview-and-sample-of-activities/0 to have a better understanding of the concepts so the understanding of this part is easier). […]