A Quality Management System (QMS) is a crucial part of a medtech startup's path to market. It demonstrates to the FDA that your company can provide safe and effective devices that meet all regulatory requirements and customer needs. A QMS comprises many interconnected elements. Do you know what they all are? Join us at this talk to get an overview from Sean O'Donnell, Chief Quality Officer at Experien Group, a consulting firm specializing in QMS, Regulatory, and Clinical support. Sean will detail the composition of QMS, explain how they interact with regulatory affairs, and describe how US agencies enforce compliance.
Where and When
Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Tuesday, February 13, 2018
Agenda
5:00 to 5:30 PM: Registration & Networking
5:30 to 6:30 PM: Talk and Q&A
About the Speaker
Sean O'Donnell is the Chief Quality Officer for Experien Group, a medical device consulting firm headquartered in northern California that helps companies develop and execute successful FDA and international regulatory programs. In addition to managing the Quality team, Sean holds particular expertise in software-based technologies as well as usability engineering standards for complex medical devices. He supports clients’ U.S. and international regulatory submissions and functions as Experien Group’s interface with regulatory agencies through audits and inspections. Sean has completed AAMI Certification for Mastery of the Quality System Regulation and a Lead Assessor Program for ISO 9000 with emphasis on ISO 13485. He was a certified instructor on Process Validation for Siemens Medical Solutions and Boston Scientific and a course instructor for De Anza College Center for Applied Competitive Technology. Sean achieved a B.S. from San Jose State University in Chemical Engineering.