The Value of a Clinical Evaluation Report Consultant for Your Devices' CER Report
The results of the clinical examination of your medical device are documented in a Clinical Evaluation Report (CER). The CER indicates that your product accomplishes its objectives without putting patients or consumers in danger. In Europe, clinical evaluation reports are required for all medical devices. You must submit your European CE Technical File to your Notified Body together with your CER attached. The Technical File is a required step in getting your device the CE Marking that is needed in Europe to sell or distribute medical devices. For all this, a Clinical Evaluation Report Consultant can be of great help.
As part of your post-market surveillance and vigilance operations, your CER should be updated regularly. Any observable modifications that have an impact on the original data should be noted and the appropriate CER added. Your compliance with the Medical Devices Directive could be hampered if you don't do that. Clinical evaluation reports will be subject to increasingly tougher requirements under the new European Medical Device Regulation (MDR), such as the foundation for establishing equivalence with a medical device. The quality of the data and other equipment are taken into account throughout your clinical evaluation.
The way to write clinical evaluation reports for medical equipment
Three steps make up a clinical evaluation. Manufacturers gather clinical data in the first phase from already published literature, clinical experience, clinical trials, or any combination of the three. The relevance, application, quality, and significance of the data are evaluated in the second stage. You must give your CER conclusion, based on the evidence you have gathered, as the third stage. Even if you incorporate the CER into your technical brief or design brief, treat it separately.
Thomas Regulatory Resolutions (TRR)
Thomas Regulatory Resolutions specializes in managing significant projects that simultaneously produce several CERs and CEPs. Active healthcare professionals who are authorities in their industries make up our subject matter experts. They offer an unmatched capacity for assessing a medical device's performance and safety critically, with particular insight into how the device directly affects patient care. We can grow resources to handle any size project because our staff is spread. To create the framework for a medical device Clinical Assessment Report, we allocate projects to subject matter experts who operate in the clinical field of the device under evaluation. We are also the best FDA medical device consultant based in Florida, USA.
We are professionals in regulating medical devices
Make sure the regulations are followed by your medical devices. Industry-leading professionals with 100% regulatory submission success rates work at TRR (Thomas Regulatory Resolutions). Our ISO Standardized regulatory services are backed by a distinctive network of subject matter specialists who are also clinically engaged. Utilizing this network gives every project unmatched talent and objectivity as well as immediate scalability for big projects. Additionally, we provide services to a global clientele that covers all clinical and medical device specialties. Our clients come from all over the world and range in size from early-stage start-ups to large multinational organizations that are publicly traded. If you need help with your regulatory strategy or have any issues, please get in touch with us.
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