A Comprehensive Guide for Medical Device Security
The 2025 Cybersecurity Checklist from Sunrise Labs provides a clear roadmap for integrating cybersecurity best practices throughout medical device development
Safeguard Your Medical Devices & Patient Data with Suntra MedTech Solutions’ Cybersecurity Expertise
Proactive cybersecurity solutions for a connected future of medical devices
Cybersecurity in medical device development encompasses the policies, processes, and technical controls used to protect devices, patient data, and clinical systems from cyberattacks. As devices become more connected and data rich, robust protections are essential.
The FDA’s premarket guidance requires manufacturers to assess and address cybersecurity risks as part of 510(k) and PMA submissions, but it does not prescribe specific methods. This flexibility lets firms tailor their approach to the device and use case; however, inconsistent rigor can leave vulnerabilities undiscovered and exploitable.
