Global Excellence, China Expertise

Medical device clinical evaluation refers to the process where the manufacture validates whether the product meets the operational requirements or falls within the applicable scope through clinical literature, clinical data, and clinical trial. We can provide Clinical Evaluation Report (CER) writing service that comply with regulatory requirements from both NMPA (National Medical Products Administration) and IMDRF (International Medical Device Regulators Forum) for regions covered by these regulations. Tigermed-Jyton has established partnerships with over a hundred well-known medical device companies globally. Most of the top 30 global medical device companies are our long-term clients. We have rapidly and professionally completed over 200 medical device clinical evaluation reports, covering more than 20 therapeutic areas, including cardiovascular, orthopedics, endocrinology, surgery, dentistry, imaging, and neurology, and others. Our team's strengths include reasonable and accurate technical comparisons, comprehensive and precise literature search and screening, rapid and accurate data extraction, adverse event information compilation, professional statistical analysis, and high-quality medical writing.

With our extensive project experience and expertise, we are able to quickly and accurately write high-quality clinical evaluation reports in Chinese and English for medical device companies, including:

Based on China's NMPA Requirements:

1. Clinical Evaluation Exemption Report: This report provides a comparison explanation for medical devices that are listed in the catalog for products exempted from clinical evaluation.
2. Predicate device clinical evaluation report
3. Overseas clinical trial / MRCT clinical evaluation report

Based on EU MDR Requirements:

EU MDR certified CER

Clinical Evaluation Strategies and Scientific Evidence:

1. Feasibility assessment report of clinical evaluation pathway for product registration (Providing companies with registration / clinical evaluation pathway decision references based on their individual strategic business needs)
2. Clinical evaluation related literature search, screening, qualitative and quantitative analysis report
3. Meta-analysis
4. Systematic reviews
5. Journal writing & publication

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