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Cybersecurity 2030: Emerging Trends in Medical Device Cybersecurity

May 23, 2023 | White Paper

How do you predict what cybersecurity requirements will be at the end of your product development lifecycle? Technology evolves rapidly, and with it, technological capabilities of threat actors seeking to profit or cause harm from malicious activities targeting...

Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act

Apr 5, 2023 | News

A “cyber device” is a device that (1) includes software validated, installed, or authorized by the sponsor as a device or in a device, (2) has the ability to connect to the internet, and (3) contains any such technological characteristics validated, installed,...

Health Industry Cybersecurity: Managing Legacy Technology Security (HIC-MaLTS)

Mar 30, 2023 | News

On March 2nd, 2023, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) published a guidance, “Health Industry Cybersecurity – Managing Legacy Technology Security (HIC-MaLTS). The same day the White House published its...

Latest Content

  • Advancing Healthcare Innovation: FDA Explores AI/ML in Drug Development and Devices May 24, 2023
  • Cybersecurity 2030: Emerging Trends in Medical Device Cybersecurity May 23, 2023
  • How, When, and Why to Leverage the FDA’s Safer Technologies Program (STeP) May 12, 2023

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