Clinical evaluation documentation is crucial in medical device registration dossiers and is often a headache for medical device companies. How should clinical evaluation be conducted? What are the documentation requirements? What materials need to be prepared beforehand? For products planned for export, clinical evaluation documentation requirements vary based on different countries' medical device regulations. What are the requirements of MDR and FDA, and how do they differ from domestic requirements?
Our Director of Clinical Medicine, Mr. Fu, delivered a presentation on "Similarities and Differences in Clinical Evaluation Documentation Requirements among NMPA, MDR, and FDA" on December 26, 2024, at 14:00. A Q&A session followed the presentation. Thank you all for participating!
Course Outline:
Time: December 26, 2024, at 14:00
Mr. Fu holds a Master's degree in Biomedical Engineering from the University of California. He has worked in the regulatory and medical departments of several multinational companies, with over 10 years of focus in medical device regulations, product certification, and clinical evaluation (equivalent devices and clinical trials).He has rich practical experience with medium- and high-risk products at the project level, having obtained over 200 domestic and international medium- and high-risk product certifications, completed and approved over 100 domestic and international equivalent device clinical evaluations, and completed and approved over 20 clinical trials. He also has multiple successful cases in special pathways such as innovative, priority, emergency, and first-of-its-kind equivalent devices.
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