Scott (Zeli) Yu, RAC.
At present, Scott provides consulting in the field of Healthcare Regulatory Services and of biocompatibility testing for medical device manufacturers in China, US, Canada and EU. He also works as a visiting tutor to lecture on US Medical Device Regulation in the RAPS EMBA class in the University of Shanghai for Science and Technology.
Scott is an expert on US FDA Inspections, CE marking and biocompatibility. With 20 years of his professional career, Scott dedicated his time and energy to 21 CFR820 conformity inspection and training, MDD and IVDD CE marking and clinical laboratory, ISO 15189 quality system establishment. He is familiar with GMP requirements in various countries and he worked closely with China CFDA to establish the China device GMP.
In addition, Scott was assigned several training courses for CFDA inspectors regarding the inspection techniques. Meanwhile, he got the opportunity to work for the US/EU diagnostic and orthopedics device company assigned CFDA oversea inspection consulting works.
Scott graduated from the Medical College Affiliated of Shanghai JiaoTong University. Prior to Qserve Scott worked on different positions of Point of Care (POC) product specialist, MDD/ IVDD Notified Body auditor and China Healthcare Manager, FDA third-party reviewer.