We are happy to announce that Qualtech offers extensive services for Clinical Evaluation Report (CER) writing. Shall a CER be of interest for your business, please refer to our brief overview below, and feel free to contact us for a first consulting session on this matter via irene@qualtechs.com.

1. Why a Clinical Evaluation Report is important for your Business

If you would like to bring your medical device into the European market and obtain a CE mark certificate, you are required to create and maintain a Clinical Evaluation Report (CER). The CER must comply with MEDDEV 2.7/1 rev 4. and MDR 2017/745. The report further represents a prerequisite document of the CE technical file, which demonstrates the safety and performance of the device under approval. 
An appropriate CER therefore provides complete clinical evidence to emphasize that your device achieves its intended use and prevents users from any adverse risks.


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2. Qualtech can assist you with your Clinical Evaluation Report:
Our medical writers are fully equipped with clinical experience, among others, with expertise in biomedical engineering and molecular biology. Based on your desired requirements, we can thus provide you with our Clinical Evaluation Report writing services for the European Union, China, Singapore, and other regions.

Qualtech’s services are as follows:

    • Search for similar products.
    • Literature search of major databases at the respective home country and abroad.
    • Database search for major adverse events after listing at the respective home country and abroad.
    • Integration of clinical literature and non-clinical data.
    • Writing of the clinical evaluation report.

3. Our Successful Cases:
We have successfully assisted numerous clients in composing CERs in order to obtain the CE mark and China NMPA certificates. We are familiar with a wide range of medical devices, such as electric therapy equipment, electrocardiographs, anesthetic ventilators, ceramic primers, contact lenses, bone cements, suture threads, and many more.

Shall you have any queries regarding a clinical evaluation report, please feel free to contact us, and our expert team will provide you with regulatory consulting according to your customized needs.