Team

Alan Wang

Principal Consultant

Alan has over 10 years of experience in the Medical Device and Combination Product industries, specializing and Quality Management and Engineering. Throughout his career, he has managed Quality departments for the development, industrialization, launch, and sustainment of on-body injectors, prefilled syringes, and drug delivery device systems.

Academic & Professional Qualifications:

  • B.S. Biomedical Engineering, Purdue University

  • M.S. Biomedical Engineering, Arizona State University

Training, Quality Systems, & Specialties:
  • ISO 13485 – Quality Management Systems
  • ISO 14971 – Risk Management
  • 21 CFR Part 820
  • Quality Engineering
  • Medical Device Design Controls and Product Development
  • Design Transfer and New Product Introduction
  • Manufacturing Process Development and Qualifications