Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of this device. This evaluation is documented in a Clinical Evaluation Report (CER).
A Clinical Evaluation is required for devices of all risks classes and should cover the complete lifecycle of a medical device.
CEpartner4U has solid knowledge of the requirements under MEDDEV 2.7-1 rev 4 and the MDR, and has experience with literature search and review of scientific articles. We gladly share this experience with you in various options:
- We assist you with writing the clinical evaluation of your device. We provide pre-completed templates and we guide you step by step to collect, appraise and analyse the clinical data pertaining to your device. In this way, you are the main author.
- We write the CER. During an initial meeting we will determine the outline of the study and the main goals. We inform you of the documentation you must provide to demonstrate the conformity of your medical devices with the essential requirements. Throughout the writing period, your participation remains essential. We are the main author and you are the evaluator.
- We can also assist you with keeping your CER up to date, or to make a gap analysis to compare your current CER with the legal requirements.
- Lastly we can train you and your team to use the MEDDEV 2.7/1 methodology. We explain the principles and the stages of a clinical evaluation. At the end of the training you will know how to write a CER. The training is available in English , Dutch and French.
We handle your data with precaution and in strictest confidence.