Cybersecurity in Medical Devices Latest Guidance: Quality System Considerations and Content of Premarket Submissions

  • Instructor : Carolyn Troiano
  • Level : Intermediate
  • Study time : 89 minutes
  • Course ID: TF3646
  • Included in Subscription Pack
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ABOUT THE COURSE

Could someone hack your medical device — and would you even know?
Do your cybersecurity protocols meet the FDA's latest expectations?
Is your team prepared to include cybersecurity in premarket submissions?


This session gives you a real-world understanding of cybersecurity risks in medical devices and how to build both safer technology and stronger documentation — from IEC 62304 compliance to the content regulators want to see.


WHAT WILL YOU GAIN
  • Clarity on integrating cybersecurity into quality systems and premarket submissions
  • A firm grasp on applying IEC 62304 and ISO14971 for risk-based software design
  • Practical best practices for preventing, mitigating, and documenting cyber threats


WHY TAKE THIS COURSE
  • Cybersecurity failures are now among the top causes of device recalls and risks
  • New FDA guidance demands clear, structured cybersecurity planning — or else
  • You'll learn how to defend your software, your submission, and your end user


KEY AREAS COVERED
  • FDA guidance and expectations for cybersecurity in medical device submissions
  • How to apply IEC 62304 lifecycle standards and ISO14971 hazard analysis
  • Building a cybersecurity plan that aligns with QMS and regulatory needs
  • Identifying top threats and system vulnerabilities in connected medical devices
  • Structuring cybersecurity risk communication and reporting requirements
  • Industry best practices to reduce risk and meet FDA premarket expectations

Quality training, expert insights, and answers that matter. Know your Expert

CAROLYN TROIANO

Carolyn Troiano has over 30 years of frontline experience in computer system validation across pharma, medical devices, and FDA-regulated tech. She helped shape industry standards like 21 CFR Part 11 and has led cybersecurity initiatives for some of the world’s biggest life sciences companies. Her expertise turns confusing guidance into practical steps your team can follow.

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