FDA’s Guidance on Postmarket Management of Cybersecurity in Medical Devices - Webinar CD/Transcript

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FDA’s Guidance on Postmarket Management of Cybersecurity in Medical Devices

How can you protect your medical devices from ever-changing cybersecurity threats?

Join Nick Sikorski and Jongbum Keum — both of Deloitte & Touche LLP, – Cyber Risk Services — for a discussion on the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016.

After this 90-minute session you’ll know:

  • What the FDA’s recommendations are for managing postmarket cybersecurity vulnerabilities
  • What manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of their postmarket management of medical devices
  • How to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA
  • Techniques for outlining circumstances in which the FDA does not intend to enforce reporting requirements under 21 CFR, part 806

Order today and get up-to-speed on what the new cybersecurity final guidance means for you.

  • QA/QC personnel
  • Data management and statistics personnel
  • Engineering and design controls teams
  • Risk management specialists
  • Compliance officers

Meet Your Presenters

Nick Sikorski, Senior Consultant, Deloitte & Touche LLP, Life Sciences & Healthcare Sector – Cyber Risk Services
Nick is the global program and solutions leader for Deloitte & Touche’s Medical Internet of Things (Medical IoT) practice responsible for securing connected and networked medical devices and additional Life Sciences products developed by medical device manufacturers.

Jongbum Keum, Senior Manager, Deloitte & Touche LLP – Cyber Risk Services
Jongbum Keum is the senior leader for Deloitte Risk and Financial Advisory’s Medical Device Safety and Security (MeDSS) practice, which focuses on helping companies secure connected and networked medical devices and additional life sciences products developed by medical device manufacturers. He brings over 18 years of experience delivering large-scale technology transformation strategy, mobilization, delivery, and governance, along with digital, cloud, and security transformation. In his current role, Jongbum advises life sciences and health care industry clients on governance, risk and compliance; product and services security; and risk management solutions.