ID2015 - 3:00p - Jones - Regulatory Challenges in Safety Critical Medical Cyber-Physical System

Regulatory Challenges in Safety Critical Medical Cyber-Physical System
Paul L. Jones
Senior Systems/Software Engineer
U. S. Food and Drug Administration
Speaker Bio

Paul Jones works at the U. S. Food and Drug Administration. He is a Senior Systems/Software Engineer in the Center for Devices and Radiological Health, Office of Science and Engineering Laboratories (OSEL) where he serves as an in-house consultant on regulatory matters involving medical device software system safety, software engineering, risk management, and safety/security assurance cases. He divides his time between transitioning high confidence software and systems (cyber-physical systems) research work into FDA’s regulatory science process and national and international standards development, and managing OSEL’s software lab.

Prior to joining FDA, Mr. Jones worked in industry for 20 years gaining extensive experience in systems/software engineering developing business systems, operating systems, configuration management systems, and quality assurance systems.

Mr. Jones earned a MS degree in Computer Engineering from Loyola College in 1999 and BSE degree in Naval Architecture and Marine Engineering from the University of Michigan in 1974.