Dexiu Shi

FAQ About Dexiu Shi

• What is Dexiu Shi's address?

  Dexiu Shi is located at
  Boyds, Maryland, United States

• What is Dexiu Shi's job title?

  Dexiu Shi is a
  Dexiu Shi, Ph.D., has more than 20 years of dedicated service to the FDA. Dexiu joined FDA in 2000 by leaving a research position in Neuroscience/Vision Science at Yale Medical School. Dexiu has been working with CDRH/ODE as an Expert physicist/Biomedical Engineer and Senior Regulatory Reviewer in the diverse areas: physics, vision science, biomedical engineering, EMC (Electromagnetic Compatibility), and software/cybersecurity for medical devices, specifically for ophthalmic, neurological, and ENT devices with applications of PMA, IDE, 510(k), HDE, De Novo and the combination (Drug-Device) products. Dexiu has been serviced as FDA Representative and Technical Expert for a variety of ISO and ANSI Standards. Dexiu also worked with colleagues at FDA OSEL (Office of Science and Technology Laboratory) on the phototoxicity assessment for medical devices, especially the OCT and the scanning systems and several joint papers and posters have been published. Dexiu also serviced for Acting Branch Chief, received special assignments to the Advisory Committees: Master Reviewer and Mentor for CDRH Reviewer Certification Program (RCP), Member of Technical Review Committee and Subject Matter Expert Reviewer for CDRH research proposals/projects. Dexiu feels it was a great honor to work at FDA and contribute to the public health mission. Prior to joining FDA, Dexiu had more than 20 years of academia and education processional career. Dexiu was lucky trained by and worked with distinguished scientists. Dexiu received her Ph.D. in biomedical engineering from Duke University, under the world-famous scientist, Dr. Maron Wolbarsht who’s a pioneer of laser application in biology and medicine. After Duke, Dexiu worked as a post-doctoral researcher at Northwestern University at the research laboratory of the Distinguished Vision Scientist and Neurophysiologist, Dr. Christina Enroth-Cugell (she earned her Ph.D. under Nobel Prize-winning scientist Ragnar Granit). Dexiu has published a volume of papers. Dexiu was the co-owner of several patents of Laser Technology Applications and Optical Fiber Positioning for Spectroscopic Astronomical Telescope and a contributor to a textbook entitled "Physics Test Questions and Answers Volume 3: Optics". Dexiu also has BS +MS training in Optical Science, Physics and Precision Instrumentation. Before coming to the United States, Dexiu was an Assistant Professor and Lecturer in the University of Science and Technology of China where she taught undergraduate and graduate courses of Optics, Laser Technology and Applications, etc. Global Medical Device Innovation And Regulation Institute

• What industry does Dexiu Shi currently work in?

  Dexiu Shi currently works in the
  Global Medical Device Innovation And Regulation Institute

• What is Dexiu Shi's area of expertise?

  Dexiu Shi specializes in
  Dexiu Shi, Ph.D., has more than 20 years of dedicated service to the FDA. Dexiu joined FDA in 2000 by leaving a research position in Neuroscience/Vision Science at Yale Medical School. Dexiu has been working with CDRH/ODE as an Expert physicist/Biomedical Engineer and Senior Regulatory Reviewer in the diverse areas: physics, vision science, biomedical engineering, EMC (Electromagnetic Compatibility), and software/cybersecurity for medical devices, specifically for ophthalmic, neurological, and ENT devices with applications of PMA, IDE, 510(k), HDE, De Novo and the combination (Drug-Device) products. Dexiu has been serviced as FDA Representative and Technical Expert for a variety of ISO and ANSI Standards. Dexiu also worked with colleagues at FDA OSEL (Office of Science and Technology Laboratory) on the phototoxicity assessment for medical devices, especially the OCT and the scanning systems and several joint papers and posters have been published. Dexiu also serviced for Acting Branch Chief, received special assignments to the Advisory Committees: Master Reviewer and Mentor for CDRH Reviewer Certification Program (RCP), Member of Technical Review Committee and Subject Matter Expert Reviewer for CDRH research proposals/projects. Dexiu feels it was a great honor to work at FDA and contribute to the public health mission. Prior to joining FDA, Dexiu had more than 20 years of academia and education processional career. Dexiu was lucky trained by and worked with distinguished scientists. Dexiu received her Ph.D. in biomedical engineering from Duke University, under the world-famous scientist, Dr. Maron Wolbarsht who’s a pioneer of laser application in biology and medicine. After Duke, Dexiu worked as a post-doctoral researcher at Northwestern University at the research laboratory of the Distinguished Vision Scientist and Neurophysiologist, Dr. Christina Enroth-Cugell (she earned her Ph.D. under Nobel Prize-winning scientist Ragnar Granit). Dexiu has published a volume of papers. Dexiu was the co-owner of several patents of Laser Technology Applications and Optical Fiber Positioning for Spectroscopic Astronomical Telescope and a contributor to a textbook entitled "Physics Test Questions and Answers Volume 3: Optics". Dexiu also has BS +MS training in Optical Science, Physics and Precision Instrumentation. Before coming to the United States, Dexiu was an Assistant Professor and Lecturer in the University of Science and Technology of China where she taught undergraduate and graduate courses of Optics, Laser Technology and Applications, etc.

• Which languages does Dexiu Shi speak? 

  Dexiu Shi speaks the following languages:
  No languages available.

• Which industries has Dexiu Shi previously worked in?   

  Dexiu Shi has prior experience in the following industries:
  Fda , Yale University School Of Medicine , Northwestern University , Duke University Graduate School , University Of Science And Technology

• What is Dexiu Shi’s work experience?  

  Dexiu Shi has the following professional experience:
  Global Medical Device Innovation And Regulation Institute , Fda , Yale University School Of Medicine , Northwestern University , Duke University Graduate School , University Of Science And Technology .

• How can I find Dexiu Shi on LinkedIn?  

  You can view Dexiu Shi’s
  LinkedIn profile at LinkedIn URL.

• What are Dexiu Shi’s work email addresses?  

  Dexiu Shi’s work email addresses are
  [email protected] .

• What company does Dexiu Shi work for?  

  Dexiu Shi works at
  Global Medical Device Innovation And Regulation Institute