The susceptibility of the healthcare industry to cyberattacks is well documented, underscored by its possession of the highest average data breach cost in recent years, which has reached nearly $11 million USD. This alarming situation prompted the FDA to strengthen cybersecurity requirements for the healthcare sector. Specifically, organizations are now mandated to include security testing documentation in their premarket submissions. In light of these requirements, our client engaged FPT Software to conduct security assessments on five products intended for the U.S. market. Using our in-house Nightwolf platform, FPT Software identified several vulnerabilities in the client’s system that had the potential to disrupt their operations and developed solutions to address these issues, enhancing our client’s security posture.