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Medical device regulatory insight · 2026-01-14

Free Live Webinar--A Complete Guide to EU Clinical Evaluation: From Overall Strategy to Efficient and Precise Literature Searching

One of the Most Challenging Areas in Global Medical Device Clinical Compliance: EU Clinical Evaluation, the Core Determinant of CE Marking Success

Free Live Webinar--A Complete Guide to EU Clinical Evaluation: From Overall Strategy to Efficient and Precise Literature Searching
Course Content:

  1. Key Points and Challenges in EU Clinical Evaluation

  2. Strategies for Developing Clinical Evaluation Pathways

  3. Common Clinical Evaluation Deficiency Letter Issues and Response Strategies

  4. How to Efficiently and Accurately Complete Literature Search and Analysis

  5. Practical Experience Sharing on the Article 61(10) Performance Route

  6. Analysis of New Clinical Evaluation Requirements and Change Trends in the 2025 MDR Draft

Course Benefits: An in-depth analysis of the key challenges and critical points in clinical evaluation from the perspective of EU clinical evaluation deficiency letter responses, with practical guidance on how to perform literature searches and analyses efficiently and accurately
Speaker Profile:

Feng Huimei - Bonnie

Founder of Shenzhen Kelin Data

Master's in Medical Imaging from The Chinese University of Hong Kong and Inner Mongolia Medical University

  • 14 yearsof experience in the medical field,Medical Officer & Clinical Lifecycle Management Manager at Siemens Healthineers,Worked as an imaging physician, and has served at Anke, Bracco, and in roles such as MDR Compliance Manager & Expert, Clinical Application Specialist, and Medical Affairs Manager
  • Led multiple high-complexity EU clinical evaluation projects, deficiency letter response solutions, and full lifecycle management (CEP, CER, PMS, PMCF Plan, PMCF Report, PSUR, SSCP, etc.)
  • Published 5 papers in Peking University core Chinese journals and 1 SCI paper (IF: 4.2); recipient of the Inner Mongolia Autonomous Region Outstanding Scientific Paper Award; holder of patents; author of an outstanding master's thesis; and editorial board member for Human Anatomy, a 13th Five-Year Plan textbook
Scan the QR code to join the group and access updated clinical evaluation materials, including original PDF documents such as ISO 18969, EU 2025/2086, the MDR COM2025 draft, and MDCG guidance