Clinical Evaluation Report Authoring
If you intend to market your medical devices in Europe, it is imperative to create and uphold a Clinical Evaluation Report (CER) that aligns with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745. The CER serves as the documented outcome of the clinical evaluation process for your medical device. This process entails the comprehensive examination and analysis of clinical data related to the device, aiming to validate its clinical safety and performance.
Clinical evaluation reports play a pivotal role in the journey towards achieving CE Marking for your medical device. A compliant CER must provide robust clinical evidence demonstrating that your device effectively serves its intended purpose while mitigating risks to both users and patients. The foundation of the CER lies in clinical data, which may encompass clinical data derived from existing literature, practical clinical experiences, clinical trials, or a combination of these sources.
We are well-equipped to assist you in the creation of your EU Clinical Evaluation Reports and in conducting literature reviews. Titans Medical specializes in the scrutiny of clinical data for medical devices, ensuring that your CER aligns with all European prerequisites. Our team of expert regulatory consultants possesses extensive clinical expertise across various medical devices and In Vitro Diagnostics (IVDs). Our services include gathering and analyzing relevant scientific literature pertinent to your device, compiling and preparing the CER in accordance with EU standards, creating procedures for compiling CERs, and conducting clinical literature reviews for future CER updates. If necessary, we can also devise a protocol for systematic searching and evaluating journal articles, culminating in a summarized overview.
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