- Presenter: Robert Klepinski, Health Law Group Attorney
Due to a recent change in FDA Medical Device Data System (MDDS) rules, systems that receive data electronically from medical devices have been declared to be medical devices themselves. Software that your practice designs or commercial software that you modify may now be controlled by the FDA. As a result, your company may have to register as a medical device manufacturer and develop a regulated Quality System to manage your software. Join Bob Klepinski as he provides an update on this law and shares useful guidelines for navigating these new requirements.