FDA Regulatory Science Lecture: Regulation of Medical Device Software/Office of Device Evaluation
Thursday, November 7, 2013
Room 2116 Chemical and Nuclear Engineering Bldg.
Professor Keith E. Herold
We will present two lectures this week.
Regulation of Medical Device Software
Cardiac Diagnostic Devices
Division of Cardiovascular Devices
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.
Office of Device Evaluation Manufacturing Reviews
Lead Reviewer, Cardiac Diagnostic Devices Branch
Brad Quinn has worked at the FDA for approximately 7.5 years. He is currently serving a detail as DCDs Senior Manufacturing Reviewer responsible for facilitating the transfer of manufacturing reviewers to DCD. This detail includes developing training opportunities, serving as a focal point for questions regarding manufacturing reviews, providing an initial-level management review of DCDs manufacturing review memos and letters, and interfacing with industry to assist in decision-making related to manufacturing submissions.
Brads full-time position is as a lead reviewer with the Cardiac Diagnostic Devices Branch where he performs reviews of 510(k)s, Premarket Approval (PMA) applications, Investigational Device Exemptions (IDEs), and Pre-submissions of devices that including patient monitors, central stations, non-invasive blood pressure monitors, external defibrillators, and other cardiac diagnostic devices.
Prior to working in ODE, Brad worked in the Office of Compliance (OC) for 6 years as a Consumer Safety Officer. During his time at OC, he performed reviews of PMAs, Establishment Inspection Reports (EIRs), recalls, consumer complaints, and regulatory/administrative actions. Additionally, Brad served two details as a Quality System Expert that included regulatory reviews and participation in policy and guidance development. Finally, he was the Network Liaison to the Cardiac Electrophysiology Matrix Network where he served as a compliance expert and represented the interests of OC in intra-Center activities.