FDAnews Announces Medical Device Cybersecurity: Latest Developments Webinar March 23, 2022 | News


FALLS CHURCH, Va., March 8, 2022 /PRNewswire-PRWeb/ — Medical Device Cybersecurity

Latest developments

An FDAnews webinar

Wednesday, March 23, 2022, 1:30-3:00 p.m. EDT


Connected medical devices must be protected against cybersecurity threats. If they are connected to networks, other devices, or the Internet, they are vulnerable to attacks that can affect their security and effectiveness.

The US Department of Health and Human Services has ranked medical devices among the top five cybersecurity threats and the FDA is pushing manufacturers for cybersecurity.

This webinar will show attendees how to integrate cybersecurity into a quality system and advocate for it to interested third parties: stay compliant, strengthen device defenses, and protect patients. Not forgetting to stay away from headlines related to security vulnerabilities.

Eric Henry, a senior quality systems and compliance advisor in the FDA and life sciences practice at the law firm King & Spalding, will discuss how to strengthen medical device cybersecurity. In particular, it will address the defense of cybersecurity during facility inspections and product submissions in light of the latest regulatory literature, including:

  • 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 unfamiliar with cybersecurity concepts
  • Link between cybersecurity risk management and product risk management
  • What regulatory documentation currently exists globally and some of the ways in which they compare to each other (e.g. FDA pre- and post-market cybersecurity guidance, AAMI TIR-57 and TIR-97, IMDRF Cybersecurity Guidelines, MDCG Cybersecurity Guidelines and various national guidance documents)
  • Common Cybersecurity Issues Identified During Inspections and Bid Reviews

Make sure devices can withstand attacks, keep patients safe… and make sure the company isn’t among the next hack-related headlines.

Interested in registering multiple sites?

Call (888) 838-5578 in the US or +1 (703) 538-7600 worldwide

to learn more about our special multisite discount.

Webinar details:

Cybersecurity of medical devices

Latest developments

An FDAnews webinar

Wednesday, March 23, 2022, 1:30-3:00 p.m. EDT


Tuition fees:

$297 by location

Easy ways to register:

Online: https://wcg.swoogo.com/md-cybersecurity

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative and business news and information for executives in industries regulated by the US FDA and European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books, and conferences to stay compliant with international standards and complex, ever-changing FDA regulations.

Media Contact

Michael ButlerFDAnews, 703.538.7600, [email protected]



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