At EPINTEK, we pride top-tier consulting services for Clinical Evaluation Reports (CERs), ensuring that your medical devices meet the stringent requirements of regulatory bodies in China, the European Union, the United States, and beyond. Our expert team is dedicated to providing comprehensive support throughout the clinical evaluation process, tailored to the specific needs of your medical device products.

Our Clinical Evaluation Consulting Services Include:

Literature Search and Analysis: We conduct thorough searches to collect and analyze relevant scientific literature pertaining to your medical devices. This ensures that all available evidence supporting the safety and performance of your product is identified and properly evaluated.

CER Drafting and Compliance: Our specialists are adept at drafting Clinical Evaluation Reports in accordance with the regulatory standards of various jurisdictions, including China's NMPA, the EU MDR, and US FDA guidelines. We ensure that your CER not only meets but exceeds the required criteria for submission.

Translation and Future Updates: We develop tailored procedures for translating your Clinical Evaluation Report into multiple languages as needed. Additionally, we perform comprehensive literature reviews to prepare for future updates of your CER, ensuring ongoing compliance and relevance.

Methodological Literature Assessment: Using a robust methodology, we search for and assess journal articles pertinent to your device. Each article is summarized and evaluated for its applicability and significance, providing you with concise briefings that facilitate informed decision-making.

By leveraging our deep understanding of global regulatory landscapes and our meticulous approach to clinical data analysis, EPINTEK helps streamline the preparation and updating of your Clinical Evaluation Reports. Whether you're seeking initial market approval or preparing for periodic updates, our services are designed to enhance the efficiency and effectiveness of your regulatory submissions.

Partner with EPINTEK to navigate the complexities of clinical evaluations and ensure that your medical devices achieve timely market access while maintaining the highest standards of safety and efficacy. Let us be your trusted advisor in this critical aspect of your product lifecycle.

For more information about our services or to tailor specific solutions, please contact our professional team.