Dr. Paul Liu
Founder, Managing Director, TFM (Test Facility Management)
Surgeon, Colorectal Surgery
Former operation & technical director and TFM of NAMSA Shanghai Lab
As the TFM of the institution, Liu exercised leadership to pilot NAMSA Shanghai Lab’s team to complete the pre-clinical studies of several products for their successful PMA/510K FDA submissions and get FDA clearance; And in 2020, it became one of the first preclinical laboratories in the medical device field in China to obtain the international AAALAC certification.
Former head of pre-clinical and clinical affairs, R&D center, Covidien then Medtronic (China)
Liu participated in the entire R&D process and post-marketing clinical follow-up of a number of core pipelines of the company; established a pre-clinical research team for the adaptation of global core active medical products to meet global emerging markets demand; and developed verification and validation methods for meeting China regulatory registration requirements. Liu built a complete tissue engineering, pre-clinical research, human factors engineering and usability study team and a methodology system for qualification of the safety and efficacy of medical devices. He is a holder of 22 US, EU and Chinese patents.
Xu Min
Laboratory Director
Graduated from Shanghai Jiaotong University, with a major in Clinical Veterinary Medicine
Master of Veterinary Studies, Attending Veterinary Practitioner, Chairman of Institutional Animal Care and Use Committee(IACUC)
Xu is in charge of the management of pre-clinical experimental surgical studies of medical devices in animals and the management of the team and GLP study facilities therefor.
As former director of pre-clinical animal experiment department and attending veterinarian of Medicilon Preclinical Research, former attending veterinarian and laboratory manager of NAMSA laboratory, Xu has more than 10 years of experience in management of GLP laboratories in CROs of drugs and medical devices.
Project experience: pre-clinical studies for more than one hundred medical devices in animals, including vascular stent, cardiac valve , cardiac pacemaker, ligament prosthesis, orthopedic plate and screw, intra-vascular embolization, vascular anastomosis, surgical robot /navigation system, cardio-electrophysiology ablation, intracranial hemangioma modeling, and heart failure/renal failure modeling, etc.
Deng Jingjing
Manager, Project Experiment Department
Shanghai Jiaotong University, Master of Biomedical Engineering
Former Study Director at NAMSA
Former senior engineer, Tissue Effect and Pre-clinical Research, R&D Center, Medtronic
Deng has developed and is familiar with bench performance testing and in vivo study methods for multiple types of energy-based devices, surgical instruments, implantable and interventional products, covering the fields of dose-effect relationship, product stability, reliability, and injury assessment.
She is profoundly knowledgeable of Chinese and international animal study related regulations, animal welfare requirements and industry standards, and much experienced in animal studies of a wide variety of products for NMPA/FDA/CE submissions, including cardio-/neuro-/peripheral vascular implantable or interventional products, major orthopedic implants, energy-based surgical tools and surgical staplers, abdominal/vascular interventional/pulmonary navigation/neuronavigator robots, surgical suture /hemostasis materials, dental implants , neurosurgical and urinary surgical implantable/interventional products, and cosmetic injectables.
Building 6, 19 Zhenglang Rd, Lingang New District, Shanghai Free Trade Zone, China 201413