FDA Regulatory Science Lecture: Regulation of Medical Device Software
Thursday, November 21, 2013
Room 2116 Chemical and Nuclear Engineering Bldg.
Professor Keith E. Herold
Cardiac Diagnostic Devices
Division of Cardiovascular Devices
Regulation of Medical Device Software
During this presentation we will discuss the importance of software design, verification and validation in ensuring the safety and effectiveness of medical device technology.
About the Speaker
Linda Ricci began her career developing artificial intelligence solutions in the defense industry. In this role she designed and developed software implementations of neural network applications. Ms. Ricci then moved to the medical device industry as a software engineer. She helped to develop several diagnostic cardiology devices as well as one therapeutic cardiology device and has participated in all phases of product life cycle development. Currently Ms. Ricci is the branch chief for the Cardiac Diagnostic Devices Branch in the Division of Cardiovascular Devices. In this role, she is responsible for the review of devices including automated external defibrillators, diagnostic catheters, electrocardiographs, multi-parameter monitors and non-invasive blood pressure monitors. She has degrees in Electrical Engineering and Medical Engineering.