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Founder & Principal, Dyad Engineering, LLC
Dr. Kate Stephenson is an engineer, researcher, public speaker, and writer. An experienced educator, she holds a PhD in Mechanical Engineering from Stanford University. After 20 years of engineering and 60 different medical devices, Kate founded a strategic consulting firm, Dyad Engineering, that works exclusively on new technologies and products in the medical field. Dyad provides strategic innovation expertise to support life science products crossing the gap from concept to manufacturing.
Introduction to Medical Device Design & Development for Practitioners
Purpose: This workshop walks practitioners through the specific design, test and documentation processes for US regulated medical devices.
Describe the 7 major stages of medical device development, from concept through being sold on the market.
Track how product requirements are established, implemented in a product, and validated for FDA approval
Understand how initial concepts are systematically engineered, de-risked and tested before being evaluated on humans in a clinical setting.