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Feng Jiang
Executive Vice President at China Association for Medical Devices IndustryDr. Jiang Feng received his M.D and PhD in Clinical Medicine in 1995, and got EMBA in 2006 ；Jiang is currently appointed the executive chairman and CEO of China Association for Medical Devices Industry (CAMDI), Chairman of China Strategic Alliance of Medical Device Innovation, Deputy Director of China National Biomedical Engineering Education Supervisory Committee. Dr. Jiang is also the standing director at many associations and guest professors at a number of universities. Jiang is also an expert consultant for the Ministry of Health, CFDA,Ministry of Science and Technology(MOST), Ministry of Industry and Information Technology, and a number of national and local medical science parks.
Dr. Jiang Feng has been the president of the 2003 Chinese medical equipment industry association and the standing vice president for 15 years. He has participated in the revision of a number of industry policies and regulations, and led the team to provide various services for more than a thousand member enterprises, making the association from the brink of marketing to the largest association in the health industry, which has been well received by members and the industry. The director of the national medical equipment industry technical innovation alliance, established by the Ministry of science and technology, has helped the Ministry of science and technology support and follow up hundreds of medical innovation projects for over 8 years, involving more than 2 billion yuan. Over the past 30 years of work in the industry, Jiang Feng is familiar with the policies, regulations, market and operation management of pharmaceutical and equipment enterprises. It has established a good relationship with many government departments, associations, domestic and foreign production enterprises, distributors, R & D and investment institutions, and serves the industry and customers with its sincerity and diligence.
HONGYAN JIANG
VP of R&D support and shared service at Shanghai Microport (Group) Medical Co.Ltd.Dr HONGYAN JIANG is VP of R&D support and shared service at Shanghai Microport (Group) Medical Co.Ltd., and also the Adjunct Professor both at the College of Food & Medical Device, University of Shanghai for Science and Technology, and at the Medical School of Tongji University. Prior to joining MicroPort, Dr. Jiang spent 13 years on biomaterials and medical devices R&D in U.S. and Germany, and was head of R&D at mNemoscience Medical. With a Ph.D. in Polymer Materials, Dr. Jiang has published more than 20 papers and 1 book, and holds for nearly 20 patents.
JIANDONG DING
Professor at National Key Laboratory of polymer molecules at Fudan UniversityDr. Ding is director of State Key Laboratory of Molecular Engineering of Polymer, and Distinguished Professor at Department of Macromolecular Science, Fudan University. He is also the chief scientist of a State Program about Biomaterials for Tissue repair and Surface modification.
He was born in 1965, and obtained his degrees of bachelor, Master and Ph.D at School of Life Sciences, Material Sciences, and Macromolecular Sciences, at the same university (Fudan University). During 1998-1999, he visited University of Cambridge supported by postdoctor fellowship of WC Wong Foundation. He won the Firs-Rate Prize for Natural Science in 2014, and selected as Fellow, International Union of Societies of Biomaterials Science and Engineering in 2016.
CHUNREN WANG
M.D., Professor and director of the Division of Biomaterials in the National Institutes of Food and Drug Control (NIFDC) at the Division of Biomaterials in the National Institutes of Food and Drug Control (NIFDC)Wang Chunren, M.D., Professor and director of the Division of Biomaterials in the National Institutes of Food and Drug Control (NIFDC). From1996 to 2001 he had worked as a guest researcher in the National Institute of Health Science of Japan for the molecular biological evaluation of biomedical materials and in the National Institute for the Advanced Interdisciplinary Research of Japan for the study of tissue engineered vascular graft and biotype artificial liver. Since April 2001 he works in the scientific research and quality control of biomaterials, disposable medical devices, medical dressing, implants and prosthetics, interventional devices, artificial organs, in vitro diagnostic reagents and tissue engineered medical products in the NIFDC.
Lane Ji
Healthcare Director of BSI China at BSILane JI is the Healthcare Director of BSI China. Lane has been working for BSI for 15 years as QMS Leader auditor, Leader Tutor, Notified Body Scheme Manager and Product Specialist for CE marking etc different roles.
Lane JI has delivered thousands of auditing, technical file reviews and training courses for hundreds of medical companies and hospitals, including IRCA ISO 13485 Lead auditor, ISO 14971 risk management, MDD directive, clinical evaluation, PMS & Vigilance, technical file and EU new MDR etc training courses.
KE YANG
Researcher at Institute of metal research, Chinese Academy of SciencesYANG Ke, Ph.D, Professor and Head of Specialized Materials & Devices Division, Institute of Metal Research, Chinese Academy of Sciences. Chair of Metallic Biomaterials Branch, Chinese Biomaterials Society. Invited Professors of Northeast University, Nanjing University of Technology and China Medical University, and the Editing Board Members of Acta Metallurgica Sinica (in Chinese & English), Journal of Materials Research Sinica (in Chinese), Journal of Iron & Steels Sinica (in Chinese), Frontiers of Materials Science in China, and Materials Technology: High Performance Materials. Leading the largest research team in the relevant area in China, and working in the areas of novel metallic biomaterials and applications, including high-nitrogen nickel-free medical stainless steel, antibacterial metals (stainless steels, titanium alloys, cobalt alloys), biodegradable magnesium alloys, biofunctionalized metals, metal coronary stents, metal orthopedic implants, etc. Published more than 500 journal papers, and awarded more than 80 China Patents.
Tingfei Xi
Center Director of Peking UniversityResearch Fellow of the frontier Interdisciplinary Research Institute of Peking University, director of Biomedical Engineering Center of Shenzhen Research Institute of Peking University, doctoral supervisor, international biological materials science and engineering Fellow, Ministry of health has outstanding contribution to young and middle-aged experts, enjoy the special subsidy of the State Council Government, the central and Central Organization Department contact experts. The head of the "thirteen. Five" special group of experts of the Ministry of science and technology, "replacement of biomaterials and tissue and organ repair". He is also the deputy director of the Chinese Society for biological materials (and chairman of the Committee for cardiovascular materials), the director of the Committee of the members of the China biomedical engineering society, the deputy chief editor of the Chinese Journal of Biomedical Engineering, and the consultant of the National Technical Committee for the standardization of medical instruments (ISO TC194) (former chairman). Member of the National Key Laboratory of Bioelectronics, the Committee of the national human organization functional reconstruction engineering technology research center, the second member of the National Center for engineering and technology research, and the expert committee of the center for cardiovascular intervention and treatment technology and equipment Engineering Research Center of the Ministry of education. The director of the member committee and the deputy director of the academic committee of the plant Key Laboratory in Shanghai Department of orthopedics, and the director of the academic committee of the Key Laboratory of the human organization regeneration and restoration of the human body in Shenzhen.
For a long time engaged in evaluation, standards and product research on biomedical materials, artificial organs and tissue engineering, 35 national and ministerial subjects are being completed or completed, and more than 280 papers (of which 98 are included in SCI) have been written or participated in the compilation of 20 books, presiding or participating in the drafting of 15 national or industry standards and applying for 8 patents. The two prize of the Chinese medical science and Technology Award (2010) was awarded in charge of "the establishment and application of medical equipment biological evaluation standard and test method". "Research on molecular biological evaluation method of medical instruments" won the two prize for scientific and technological progress in Zhejiang province (2007). "Research on the biological evaluation standard and test method of medical instruments" won the Beijing Municipal Science The two prize for technical progress (2002).
XIANG DAN JIN
Quality regulation expert at Lepu Medical Technology（Beijing）Co.,LtdEngaged in medical equipment industry for 14 years, focus on medical equipment CFDA registration, CE, FDA, KFDA and other overseas registration, certification and consulting work. Product categories are widely involved, with passive high risk implants and accessories products, active medical devices, and extracorporeal diagnostic reagents, with a total of more than 40 products of CFDA notes. Certificate, more than 100 products of CE certification (30 of them for high risk medical equipment), more than 10 products of FDA 510 (K), more than 130 national registration certificate; at the same time as a EU certification body cooperation speaker, in the form of case analysis to domestic enterprises and foreign enterprises to speak more than 10 fields.
At the same time, the Foreign Drug Supervision Bureau has undergone dozens of on-site audits, including FDA site combing and more than 10 times, the CFDA GMP field combing and 20 times, and the CE site to comb the level of more than 20 times.
She has 14 years of experience in the quality management of medical equipment production, and the experience of medical equipment certification. She is good at the compliance of various countries or regions, the application of risk in the clinic and the effective management of the quality system.
YANAN XU
General Manager，Medical Device Regulation consultant at Beijing Pro-MedSci Co., LtdWork in the field of product safety laws and regulations for more than ten years, and make in-depth research on the regulatory system of CFDA for medical devices. Provide regulatory/clinical trial consultation to nearly 100 domestic and foreign medical device companies, and have rich experience in clinical trials of implanted and interventional devices, quality control，and etc. Pro-Medsci has extensive and in-depth researcher resources in the field of cardiovascular and cerebrovascular diseases. It has successfully assisted many cases of stents, balloons, valves and other products to complete the registration study, as well as other dental and orthopedic products such as implants and joints. Helping companies break through regulatory barriers and avoid risks quickly and at low cost.
RENJIE XU
Deputy chief physician at SUZHOU MUNICIPAL HOSPITALDr. Xu RenJie graduated with a medical doctor degree from Peking University in 2009. In 2012, he studied in Germany as a visiting scholar. Now he is deputy chief physician in orthopaedic department of Suzhou Municipal Hospital, specializing in joint surgery and ankle surgery. He is the 333 highest level talents in Jiangsu province, the key personnel of youth medicine in Jiangsu Province, master's supervisor of Nanjing Medical University and postdoctoral fellow of Soochow University.
Markus Marquart
Product Manager Medical Technology’s at INDEX Trading (shanghai)CO.,Ltd.INDEX-Werke GmbH & Co., KG Hahn & Tessky
seit:08.2015
Product Manager Medical Technology’s
06. 2003 - 08.2015
Application team leader and training consultant
focus TRAUB - TNL Swiss Type Series
03.2001 - 05.2003
Technical Engineer TRAUB TNL Swiss Type Series
>>Application and Technology <<
02.1998 - 08.1999
Technical Engineer：TRAUB TNL Swiss Type Series
>>Development and assembly<<
Michael Qian
CEO of StarArc Coating Advanced Material Technologies (Suzhou) Co., LtdExpert in PVD coating technologies and system design; Tecnopioneer of Suzhou Industrial Park; Industry Professor of Soochow Univeristy; More than 20 patents in US,Singapore and China; Working experience on thin film in the industry of semiconductor/disk drive at Nanyang Technological University, Seagate etc.; Founder of Stararc.
Frank Shi
Business Manager_AMPD Great China at RennishawMr. Frank Shi, Business Manager_AMPD Great China，Rennishaw. Since 2007, Mr. Frank Shi has worked in Objet, Stratasys and many other leading enterprises in the field of 3D printing. In 2015, he joined Renaissance as China Sales Manager and in 2017 as China Business Development Manager.
KL
Kean Chong Lee
Section Head - Product Develop, Value Stream Engineering at Bemis Flexible PackagingBemis Asia Pacific Product Development Engineer, Section Head of Product Development, Value Stream Engineering. Lead a team of Product Development. Engineers in AP Region (Healthcare Division) who are focused on new product development and technical support. Work based in Bemis Malaysia but travel around Asia Pacific Region to provide customer support.
Liyu Shen
Technical Engineer at Horn（Shanghai)International Trading Co.,Ltd
Xiuqin Zhang
Deputy general manager at Shanghai Sunshine Digital Medical Co.,LtdGraduated from Shenyang University of Technology, school of economics and trade,management accounting, once served as general manager of Beijing Jianzhong Metallurgical Investment Co. Ltd, currently, she is deputy general manager of Shanghai Sunshine Digital Medical Co.,Ltd, fully responsible for the operation and management of the company.
QL
QING LIU
CEO of Beijing Advanced Medical Technologies, Ltd, IncPartial List of Invited Speaker
Mr. Senyong LIN
Shanghai Municipal Food and Drug Administration, Medical Device Safety Supervision Office, Director
Ms. Hong Qian
Shanghai food and drug administration, certification and Accreditation Center，Chief assessor
Mr. Sa Dun
United States Food and Drug Administration Office in China, Assistant Director
Mr. Weibin Chen
DEKAI Holding Group， East Asian District Director
Ms. Heyan Dong
Chairman of National Committee for the Branch of Cardiovascular Implant President of Dalian Medical Equipment Industry Association
Board Chairman of Liaoning Biomedical Materials R&D Center Co., Ltd.
Mr. Qiqing Zhang
Chinese Academy of Medical Sciences, Institute of Biomedical Engineering，Ph. D., doctoral tutor
Mr. Xiaodong SONG
Senior R & D engineerđTrauson (China) Medical Instrument Company Limited