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

Friday, March 24, 2017 · 1:30 p.m. - 3:00 p.m. EDT

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 — on March 24 when they’ll discuss the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016.

After this 90-minute webinar 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

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

Webinar plus Audio CD/Transcript
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$487

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Webinar only
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$287

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24/7 Encore plus CD/Transcript
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$487

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24/7 Encore Presentation
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$287

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Audio CD/Transcript
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$287

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Who Will Benefit

  • 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.

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