Navigating the new cyber security activities required by the FDA

All legally-marketed medical devices have benefits and risks. Threats and vulnerabilities cannot be eliminated, and reducing cyber security risks is incredibly challenging. The health care environment is complex, and manufacturers, hospitals, and facilities must work together to manage cyber security risks. Join us as we team up with Christopher Gates from Velentium to present you a webinar on Navigating the new cyber security activities required by the FDA. He will guide you through all 40 of the new activities and deliverables as envisioned by the FDA in their latest premarket guidance on cyber security. This new approach is extremely invasive to normal medical device development efforts, and developers need to plan ahead to minimize the impacts on development while improving their cybersecurity posture.

Webinar presenter

Christopher Gates Director of Product Security at Velentium Christopher Gates is the Director of Product Security at Velentium. He has over 30 years of experience developing and securing medical devices and works with numerous industry-leading device manufacturers. He frequently collaborates with regulatory and standard bodies including the CISA, MITRE, Bluetooth SIG, H-ISAC, Health Sector Coordinating Council, and the FDA to present, define, and codify tools, techniques, and processes that enable the creation of secure medical devices. Gates promotes the “secure development lifecycle,” the industry-leading approach that ultimately eases the burden on developers and ensures high-quality products that work as intended to save and improve lives.