Applying QMS Fundamentals to Cyber Security and Interoperability.
Using old methods to address new challenges.
Wednesday, August 28, 2019, 7:00 to 9:00 pm
Topic: Applying QMS Fundamentals to Cyber Security and Interoperability. Measure and monitoring of processes
As medical devices increasingly operate in a connected environment; safe and effective interoperability is foundational to assuring security and privacy. The recently published AAMI-UL 2800-1 and ISO 27000 series of standards provide requirements for life cycle processes for managing interoperability and cyber security risks. These processes rely on quality management basics.
This seminar will cover the essential requirements from these standards and discuss how quality principles can be applied to integrate interoperability and security into the QMS.
Dr. Geetha Rao has over 20 years of experience in medical technologies with a focus on emerging business challenges and operational excellence that meets best-in-class, international standards. She is an internationally recognized expert in risk management and liability and has served on several international policy making bodies, and as an invited expert to regulatory agencies, including the FDA, ISO Technical Committees, GHTF, and European Notified Bodies. Her focus has been on regulatory and legal problem-solving for submissions, FDA and notified body inspections and audits, adverse events, and liability. She has addressed numerous industry forums and the press on issues of management of product and process quality and business risks. Dr. Rao is a long-time member of the ASQ Biomedical Division Northern California Discussion Group. She is a graduate of the Indian Institute of Technology, Madras and holds a doctorate from MIT and a master’s degree from Stanford University’s Graduate School of Business.
Location: Stellartech Research Corporation, 560 Cottonwood Dr., Milpitas, CA 95035
Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.
Email: To be added to or removed from our email list, contact George Marcel, firstname.lastname@example.org.
Registration Link: http://ncdgaug2019.eventbrite.com/ONLY Check or Credit Card accepted at door
Questions: For information about this session, contact: Geetha Rao, at email@example.com
Formal discussion and questions will end between 8:30 - 8:40 pm to allow time for networking.
Materials: Presentation & workshop sheets provided for onsite attendees only. Please limit distribution to attendees: personal professional use only.
Webinar Remote Access (no cost):
Milpitas, CA 95035