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A cyber attacker gains access to a care provider’s computer network through an email phishing attack and turns off all ICU heart monitors, putting multiple patients in peril. This was the realistic scenario put out in a report from the U.S. Department of Health and Human Services, which listed medical devices as one of the top five cybersecurity threats.
Likewise, the FDA is pushing manufacturers on cybersecurity — an estimated 70% of devices are running outdated, no-longer-supported Windows operating systems. A surprising number have critical vulnerabilities for which a patch was long-ago available.
If your medical devices are connected to networks, other devices or the internet, they’re vulnerable to attacks that can impact their safety and effectiveness.
This webinar will show you how to incorporate cybersecurity into your quality system and defend it to interested third parties: you’ll stay compliant, bolster your device defenses and protect patients. Not to mention stay out of security breach-related headlines.
Eric Henry, a Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding, will explain how to bolster your medical device cybersecurity. In particular, he’ll address the defense of cybersecurity during facility inspections and product submissions in light of the latest regulatory literature.
Webinar Takeaways:
- How cybersecurity relates to design controls and the quality system more generally
- Key tips for defending cybersecurity during an FDA inspection or notified body audit, even when the investigator or auditor is not familiar with cybersecurity concepts
- How addressing cybersecurity risk relates to product risk management
- What regulatory literature currently exists globally and some of the ways they compare to each other (e.g., FDA premarket and postmarket cybersecurity guidances, AAMI TIR-57 and TIR-97, IMDRF cybersecurity guidance, MDCG cybersecurity guidance, and various national guidance documents)
- Common cybersecurity issues identified during inspections and submission reviews
Ensure your devices can withstand attack, keep patients safe… and make sure your business isn’t part of the next hack-related headline. Join us by registering today.
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Webinar plus Recording & Transcript Bundle
Learn more
Best Value! You’ll have access to one log-in for the live 90-minute webinar for unlimited participants. You also receive all presentation materials and the opportunity to ask questions by phone and email, plus an audio recording and transcript for the entire session. Delivery is approximately two weeks after the session.
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$487
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Webinar only
Learn more
You get one log-in for the live 90-minute webinar for unlimited participants, presentation materials and the opportunity to ask questions by phone and email.
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$287
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24/7 Encore plus Recording & Transcript Bundle
Learn more
You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately two weeks after the session.
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$487
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24/7 Encore Presentation
Learn more
You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can log in any time of day or night. You'll also receive all presentation materials.
|
$287
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Webinar Recording & Transcript Bundle
Learn more
You'll receive an audio recording and written transcript of the entire 90-minute webinar, including the Q&A period, and all presentation materials. Delivery is approximately two weeks after the session.
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$287
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Who Will Benefit
- Software Engineers
- Quality Assurance Personnel/Engineers
- Regulatory Affairs Personnel
- Legal Personnel
- Functional and Business Leaders
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Meet Your Presenter |
Eric Henry
Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences
King & Spalding
Eric Henry is a Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding. He has 30 years of global leadership and practitioner experience in a variety of quality, compliance and product development roles, with a specialization in large organizational change and remediation programs, software quality (including cybersecurity), medical device design controls, risk management, audit management and management controls. Prior to joining King & Spalding in late 2018, Mr. Henry led global technical and quality organizations at Philips, Medtronic, GE Healthcare, Boston Scientific and Hologic. Prior to entering the medical device industry, he led a software quality management and program management office consulting capability in the Washington, D.C. area and held software design and development leadership roles in a small startup, a mid-sized healthcare software company, a large financial services regulator and stock market and a large retail organization. |
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