Medical Device Security That Protects Patients, Beyond Inventory Alone
Your infusion pumps, imaging systems, and patient monitors are on the network. Your security team is lean, your device inventory is incomplete, and patching a clinical device is never as simple as patching a laptop. We help you find every device, prioritize the real risk, and build a program that holds.
Connected medical devices keep clinical operations running, and they expand your attack surface every year. Most healthcare organizations cannot answer three basic questions with confidence. What devices are on your network? Which ones carry the greatest risk to patient safety and data? Who owns fixing them?
The pressure is real and healthcare-specific.
Medical device risk sits at the intersection of cybersecurity, clinical operations, compliance, and patient safety. It needs a program, not a one-time scan.
If you build the devices instead of deploying them, the version of this problem is different but no less real. FDA premarket cybersecurity expectations, not network visibility, are the gate you have to clear before a device ever reaches a hospital network.
We meet you wherever you are today on your medical device journey and build toward a governed, sustainable program. Every engagement runs through Meditology’s Advise, Implement, and Manage model, so you can start with a focused assessment and grow into a fully operational program. We offer four named services along that path.
(most budget-friendly starting point)
This lays the foundation. We perform device discovery and build an accurate inventory, then run a structured risk assessment against the frameworks that govern healthcare environments (HIPAA Security Rule, NIST CSF 2.0, HITRUST CSF, and FDA guidance). You receive prioritized corrective action plans that rank remediation by patient-safety and data-risk impact, not by raw vulnerability count.
We orchestrate the fix. This service coordinates patching and remediation across your clinical engineering, IT, and security teams, and manages the vendor coordination that medical device remediation always requires. We work within vendor terms and FDA-cleared configurations so clinical uptime is protected.
This is the strategic layer. We build a multi-year blueprint and roadmap that defines governance and roles, aligns to your chosen security control frameworks, and sets the operating rhythm for the program. The blueprint covers compliance alignment, incident response for connected devices, and threat modeling that reflects how your devices function in clinical workflows.
Full-service program development and ongoing operation, supported by embedded subject-matter experts who work as an extension of your team. This is the “Manage” tier, delivered through RITHM, Meditology’s continuous-engagement model, so the program runs with a predictable rhythm rather than in fire-drill bursts.
The four services above secure devices already deployed inside a health system. Device manufacturers and health tech suppliers building the devices face a different gate, FDA premarket cybersecurity expectations. We support the cybersecurity documentation and 510(k) submission readiness a manufacturer needs before a device ships, including Software Bill of Materials and Section 524B obligations.
This is advisory and program depth: discovery, risk, remediation orchestration, and governance. When you need hands-on adversarial testing of devices, we cross-link to Meditology’s Medical Device & IoT adversarial testing capability in our Adversarial Testing domain. The program work here defines what to test and what to do with the findings; the testing capability executes the hands-on attack simulation. The two connect, and we do not duplicate testing scope inside the program services.
Concrete deliverables, tailored to the service tier you start with.
Medical device security splits into two conversations that most firms only have one side of. Health systems need to secure devices already on the network. Manufacturers need to satisfy FDA premarket expectations before the device ships.
Meditology works both sides, which changes the provider conversation: when we assess your deployed fleet, we know what the manufacturer was required to demonstrate and what their SBOM should tell you. It changes the manufacturer conversation too, because we know how your device will be assessed once a health system deploys it.
Governance across clinical engineering, IT, and security, mapped to HIPAA, NIST CSF 2.0, HITRUST CSF, and FDA guidance, with vulnerability prioritization tuned to clinical risk rather than CVSS alone.
The Medical Device Risk Assessment service is the most budget-friendly entry point. We run device discovery, reconcile it against your records, and deliver a prioritized risk picture. That assessment becomes the foundation for everything else.
The Medical Device Security Remediation service orchestrates patching and remediation and coordinates with device vendors. We respect FDA-cleared configurations and vendor terms, and we sequence remediation so clinical uptime and patient safety come first.
This is advisory and program work: discovery, risk assessment, remediation orchestration, and governance. Hands-on adversarial testing of devices is delivered through our separate Medical Device & IoT adversarial testing capability. The program defines what to test and acts on the findings; testing executes the attack simulation. We connect the two without duplicating either.
Yes. We support FDA premarket cybersecurity documentation and 510(k) submission readiness, including SBOM and Section 524B obligations. Talk to an advisor about your device and your submission timeline.
HIPAA Security Rule, NIST CSF 2.0, HITRUST CSF, and FDA guidance, mapped so evidence collected once is credited across the frameworks that share underlying controls.
Yes. The Managed Medical Device Security Program develops and operates the program with embedded subject-matter experts, delivered through RITHM with a predictable operating rhythm and a ≤ 2-hour response SLA on managed control-owner support.
Healthcare is a trust relationship. Let us help you protect the connected devices your patients depend on.
Schedule a 30-minute conversation to walk through your current device landscape and identify where to start.
