Your Challenge You know unintentionally insecure medical devices can put patients’ safety and data–and your organization’s reputation–at risk, so you understand the impetus behind the FDA’s cybersecurity regulations. However, working through their process takes a long time. You need a partner that can help you accelerate the pre-market submission process so you can bring a secure, effective device to market sooner.
Our Solution End-to-end security testing of your device throughout the product release cycle enables you to leverage our attacker perspective to identify material security risks to your patients and organization. Collaborate with our adversarial experts to develop the necessary documentation to confidently tell your security story.
Your Challenge Most modern medical device ecosystems now reside in the cloud, which means effective postmarket monitoring is critical for ensuring their ongoing safety and efficacy. However, your internal team has an expansive mandate and needs a partner who can provide ongoing vigilance to address evolving threats, and who will maintain their focus so your internal team can attend to other priorities.
Our Solution Combine attack surface management and continuous penetration testing to ensure comprehensive postmarket monitoring. Our adversarial managed service team, enabled by our continuous offensive security platform, Chariot, provides greater breadth of assessment and time-on-target than one-off penetration testing can provide. Praetorian helps you address the FDA’s postmarket monitoring requirements in the following ways: Monitor–Gain continuous, comprehensive, and contextual asset discovery and vulnerability monitoring when you integrate Chariot with your cloud providers, source code managers, container registries, workloads, and ci/cd pipelines. Identify–Save your internal team time and energy by eliminating the triage process. They can be confident that any alert from our team represents a material risk that adversarial engineers have verified as an exploitable attack path. Address–Validate that remediation steps were effective and operate within the guidelines of your vulnerability disclosure processes.
How Praetorian can help you secure your devices The strategies your organization adopts for its pre-market submissions and post-market monitoring directly affect the likelihood of your medical devices receiving market release approval from the FDA. A holistic offensive security approach is the best way to ensure your device not only makes it to market, but remains secure into the future.
Medical Devices Need Offensive Security Medical devices have changed significantly since 1976, when the FDA first began regulating them. The related sciences have progressed, leading... View Report