A Clinical Evaluation Report (CER) is a medical device safety and assessment report. It is based on clinical data gathered through clinical research and other studies on the device. A Clinical Evaluation Report (CER) documents the findings of your medical device's clinical evaluation. A CER is made up of analyzed clinical data from your device's clinical investigation or the results of other studies on substantially equivalent devices.

A well-researched Clinical evaluation report gives regulators like notified bodies, competent authorities, patients, and clinicians alike confidence that medical devices have been validated by strictly adhering to guidelines, ensuring that their potential benefits outweigh any potential risks.

The Best Clinical Evaluation Report Consultants At Thomas Regulatory Resolutions
Clinical Evaluation Report Consultant

How to Write a Medical Device Clinical Evaluation Report?

A clinical evaluation consists of three steps. Manufacturers identify clinical data in step one by searching existing literature, clinical experience, clinical trials, or any combination of the three. The second stage entails assessing the data's relevance, applicability, quality, and significance. The third step requires you to express your findings in the CER based on the data you gathered. Even though it will be included with your technical file or design dossier, treat the CER as a separate document.

The following are some possible elements to include in your CER:

General data: device and manufacturer names
Short physical and technical device description, as well as the intended application
A summary of the intended therapeutic or diagnostic claims
Data types and clinical evaluation
Clinical data summary and review
Describe the analyses that were used to evaluate the performance, safety, and relevance/accuracy of product literature.
Safety, performance, and conformity conclusions
Why Choose Us?

Thomas Regulatory Resolutions offers a one-of-a-kind solution that includes the creation of a Clinical Evaluation Plan (CEP), a Clinical Evaluation Report (CER), and the certification of the physician. Our partners have a good network of National Board Certified Physicians who conduct the risk-benefit analysis and provide the required certification.

We complete the regulatory aspects of CER such as product information, PMS, Risk Management, and so on, while our partner works on the clinical aspects such as defining the evaluation strategy, conducting literature searches, risk/benefit analysis, and so on, as well as final physician certification.

Clarity and structure are at the heart of everything our Clinical Evaluation Report Consultants do at Thomas Regulatory Resolutions, in line with the expectations of European authorities. Our primary goals are to ensure thoroughness and scientific accuracy at every stage of data collection and presentation in the CER, and receiving approval is the clear endpoint for every report we create.

Clinical investigations is identified as a method of assessing the benefit-risk ratio of medical devices in the EU MDR. Furthermore, risk assessment can be used to justify any potential risks to trial subjects when weighed against the benefits. These should be thoroughly documented in the clinical research plan. The plan must also include an ongoing risk monitoring strategy and a benefit-risk ratio.

Working in collaboration with our CER Consultants, we strive to provide every detail requested and more, while maintaining a keen eye on objectivity, completeness, and evidence-based content throughout the process.

Our FDA Emergency Use Authorization EUA Consultants Are Ready To Assist You

Obtaining FDA clearance for a medical device for sale in the United States is a time-consuming process. The average FDA 510(k) submission takes 5+ months to clear from the time it is submitted, not including the prep work. When the COVID-19 pandemic hit, the FDA recognised the need to significantly accelerate the approval process for certain types of equipment used to detect/protect/treat COVID-19 patients and the healthcare workers who care for them. This is why the FDA established an Emergency Use Authorization (EUA) pathway for certain COVID-19-related items.

Contact us today to reduce the time it takes to submit a EUA. Our FDA Emergency Use Authorization EUA Consultants have assisted numerous medical device and IVD companies in obtaining FDA Emergency Use Authorizations in response to COVID-19, and we are ready to assist you as well. Call us at +1 561 898 0260 or submit an inquiry online for the quickest response. We ensure the least burdensome approach to regulatory issues, quality management systems and compliance, in a streamlined and value-added way. Rest assured that you can leverage our expertise to optimize your medical device company's efforts.