Description

A great deal of attention in medical devices has shifted towards cybersecurity with the ratification of section 524B of the FD&C act. Essentially this new law enables the FDA to enforce cybersecurity controls in any medical device that is capable of networked communications or that has software. At the end of this process are the tools and practices to fix vulnerabilities in devices. While the objective sounds straightforward, a breakdown of the categories of fixes and their management is often involved. 

In this webinar we will: 

Recap the process for managing vulnerabilities 

Identify the categories of vulnerabilities and solutions 

Describe the methods for applying mitigation: OS Kernel mode drivers Open source Custom application software 

Provide an overview of Software Bill of Materials (SBOM) and explain why it’s relevant but challenging 

Discuss Cybersecurity reporting to the FDA including the handling of CVEs and the role of Penetration testing

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