Helene Chon, Principal
Helene Chon is a cross-functional medical device and combination product (FDA Class I, II, III) expert. Her intense curiosity has led her to accumulate 25+ years of diverse experience in development, manufacturing, and quality engineering functions as well as functional and cross-functional leadership roles. Coupled with a knack for systemic thinking, her versatility enables her to apply a holistic approach to the development of complex devices, DHFs, RMFs, and quality systems. She is also a prolific writer with endless patience for integrating cross-functional feedback into her work.
Helene holds a BSME from Stanford University and an MBA from SFSU.
– Expertise: design control (including verification and validation), risk management, human factors, statistical techniques, test method validation, equipment qualification, process validation, cGMP, root cause analysis
– Therapeutic Areas: virology, oncology, ophthalmology, endocrinology, cardiology, gastroenterology
– Product Types: implant, pen injector, prefilled syringe, kit, IVD device, catheter, electromechanical device
– Manufacturing Processes: formulation, fill/finish, injection molding, assembly, labeling, packaging, UDI, serialization
– Regulations/Standards: 21 CFR Parts 3/4, 210/211, 600, 809, 820; EU MDR/IVDR; ISO 13485, 14971
– Tools: Minitab, JMP, Excel, Solidworks, Veeva