What We Do?

CDAQI research provides support in the creation of a new clinical evaluation report as well as updating existing clinical evaluation.
A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analysed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices. The CER demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.
Clinical Evaluation Reports are required for all medical devices in Europe. You must submit your CER to your Notified Body as an attachment to your European CE Technical File.
Clinical Evaluation Reports is prepared as per Annex XIV, Part A of Regulation (EU) 2017/745.
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How to prepare a Clinical Evaluation Report for medical devices
- General information:device and manufacturer name
- Concise physical and technical devices description and intended application
- Outline of intended therapeutic or diagnostic claims
- Clinical evaluation and data types
- Summary of clinical data and review
- Describe analyses used to access performance,safety,and relevance/accuracy of product literature
- Coclusions about safety,performance,and conformity
