MATTER Workshop: Medical Device Development
January 16, 2018
9:30 AM - 11:00 AM
222 W Merchandise Mart Plaza #1230 Chicago, IL, Chicago, IL
Medical device entrepreneurs often wonder when it’s time to move from tinkering and bench top testing to a more formal product design process. The FDA’s design controls guidance document is a great resource but it doesn’t really address the pragmatic aspect: when should we start following these guidelines? Lilli Zakarija, founder of EdgeOne Medical will share best practices and insights from her 20+ years of medical device design and development experience. Specifically, she will introduce concepts and principles that are the cornerstones of successful product design and development in the healthcare industry. Critical topics include: introduction to the FDA’s guidance document on design controls, different phases of product development, customer (user) needs, product requirements, design iterations, design reviews, risk management, verification and validation. Case studies from medical device start-ups across various sectors will be utilized to demonstrate various pathways of rolling out a development project under design control.
Jan 4, 2018
Jan 4, 2018