RAPS Twin Cities Chapter: Cybersecurity: An Overview of Meeting US and Global Regulatory Requirement

When:  Oct 9, 2017 from 07:30 to 11:00 (ET)

Cybersecurity is becoming more and more important in the regulation of medical products. In May 2017, the US Food and Drug Administration (FDA) conducted a public workshop on medical device cybersecurity, the agency's third on the subject to date. At this workshop, FDA officials, industry representatives and researchers tried to determine the current gaps in regulatory science as it relates to cybersecurity. The FDA officials aim was to come up with fixes for those gaps down the road.

US Premarket Submissions for connectable medical and IVD devices will need to address how security risks have been identified and managed.  However, what exactly does that mean? This presentation will highlight the current US requirements and offer practical strategies for meeting premarket submission guidance. In addition, it will highlight emerging global thinking on managing cybersecurity for connectable medical devices as well as discuss universal approaches to help companies meet the increasing demand for safe and secure medical devices and software.

Come explore this important topic over breakfast with other regulatory professionals from your region and Laura Elan, practice lead for UL’s digital health and cybersecurity practice. This program is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. Breakfast will be provided. RAC holders may claim three RAC recertification credits.