Expert guidance, checklists, and best practices to help you navigate FDA requirements, cybersecurity compliance, and regulatory standards.
In-depth guidance from our team of medical device software experts
Comprehensive guide to FDA cybersecurity requirements for medical device submissions, including architecture security views, threat modeling, and testing requirements essential for regulatory approval.
Technical guide covering secure boot processes, cryptographic verification, and trusted update mechanisms to protect medical devices from cybersecurity threats during software updates.
Analysis of Section 524B of the FD&C Act and how new FDA cybersecurity regulations make remote software update capabilities practically required for medical device manufacturers.
Our experts provide tailored advice for your specific regulatory and technical challenges.