We are more connected than ever, a trend that increases with the continued adoption of wearable technology and cloud-based data systems. Medical devices are no exception, and this makes them vulnerable to breaches which could affect critical and non-critical functions, data integrity and personal information security. In 2014, FDA published new guidance on Cybersecurity of Medical Devices and the agency is now actively looking for evidence in submissions as to how companies intend to both mitigate risk of security breaches in the device design, and plans for ongoing maintenance, e.g. security software patches to prevent cyber-attacks. In this webinar, UL experts who sit at the table with the regulatory agencies will discuss the current guidance for Cybersecurity in the medical industry and provide strategies for how companies can demonstrate to regulators, purchasers, and users that threats related to Cybersecurity have been addressed.
Anura Fernando – Principal Engineer – Medical Software & Systems Interoperability
Anura holds degrees in Electrical Engineering, Biology/Chemistry, and Software Engineering with 17 years of UL experience in safety critical software & control systems certification including cross-industry research in automation, energy, medical, nanotechnology, etc. He has global responsibility for medical software certification at UL and is UL’s technical lead in developing the AAMI/UL 2800 standards for interoperable medical device safety. He has served on the Federal Advisory Committee FDA Safety and Innovation Act (FDASIA) WG, Medical Device Interoperability Coordinating Council, Medical Device Interoperability Safety WG, NIH QMDI Program Advisory Committee, and a number of interoperability-related committees with AAMI, IEC, and ISO. He is also an active member of a number of industry consortia and professional organizations working on medical device interoperability, including the Association for the Advancement of Medical Instrumentation, the Health Information Management Systems Society, and the International Council on Systems Engineering.
Laura Élan, P.E.- Program Manager – Life & Health Sciences
Laura Élan is the Global Service Leader for UL’s eHealth and Interoperability Business, a part of the UL’s Life & Health Sciences Business Unit. Ms. Elan rejoined UL’ Life & Health Sciences Business Unit in 2012 and serves as the subject matter expert in medical device software and usability certification. She is has over 25 years of experience with software, product development, and compliance engineering, grounded in several decades of senior leadership roles with R&D and Manufacturing organizations including Pharmaceutical, Medical Devices, Commercial and Consumer Electronics companies. She has led cross functional product development organizations as both a technical and operations leader. Ms. Élan holds a Bachelor degree in Electrical Engineering from the University of Illinois, Urbana, and a Master of Science in Electrical Engineering from the Illinois Institute of Technology and is currently pursuing a Graduate Degree in Computer Science with a focus on cybersecurity. She is a licensed Professional Engineer in the State of Illinois.