#404: MedTech 101: What You Need to Know About the Medical Device Industry
Etienne Nichols hosts Sara Adams and Chris Rush from Greenlight Guru for a foundational overview of the medical device industry. They define medical devices by intended use and labeling, distinguishing roles for Quality, Regulatory, Clinical, and R&D teams. The trio explains FDA classifications (Class I, II, III), regulatory pathways like 510(k) and PMA, and key standards including ISO 13485 and ISO 14971. They emphasize the importance of design controls, risk management, and reading regulations to navigate compliance and market access.