"Medical Device and IVD Regulatory Overview"
Sandra D. Maher. M.S.
Independent Regulatory Affairs Consultant
To attend virtually via Zoom, register HERE.
Have you ever wondered what it takes to take a medical technology through the FDA? Join us for a discussion on Medical Devices and an IVD Regulatory Overview to help you better understand some of the considerations for determining a product's regulatory route to market. This introduction is for professionals new to medical device and IVD regulatory affairs and looking for an opportunity to learn more about regulatory requirements for bringing products to market.
Sandra D. Maher, M.S., Regulatory Affairs Consultant (Medical Devices and IVDs), will cover topics including defining a medical device and an IVD, reviewing basics about device classification, identifying different types of premarket submissions, and describing how to get a new product to market.
This event is the 5th session in the 2022-2023 Bench2Market Talks series, which was created to provide commercialization guidance to the university research community.