Wireless access points are often the easiest path into a network. We test corporate Wi-Fi, guest networks, and device-to-device wireless protocols.
250+ FDA submissions. Zero rejections.
Wireless on a medical device is rarely just Wi-Fi. BLE pairing, proprietary RF telemetry, MICS, NFC, and cellular fallback each need their own protocol-aware testing - and reviewers expect every one of them in the report when they exist on the device.
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
Every wireless penetration testing engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Every wireless penetration testing engagement produces evidence aligned to the regulatory and consensus standards FDA reviewers and notified bodies expect to see - traceable, complete, and ready to drop into your ISO 13485 quality system.
Defines the SPDF, Section 524B submission package, threat modeling, SBOM, security architecture views, and cybersecurity testing every cyber device submission must include.
The consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
Reference methodology for planning, executing, and reporting security testing.
Industrial-strength secure-development-lifecycle requirements applied to connected medical devices.
Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about - and what this engagement is built to cover.
Unauthenticated and unencrypted proprietary RF telemetry between implants and home monitors. The single advisory most often cited when reviewers ask for evidence that proprietary RF was tested, not just Wi-Fi.
Family of BLE link-layer vulnerabilities affecting multiple medical and consumer SoCs. Drove the FDA expectation that BLE stack version, vendor advisories, and patch posture are documented in the cybersecurity package.
FDA-compliant device, firmware, app, and cloud testing.
View Medical Device Penetration Testing10+ years testing medical devices for 510(k) and PMA clearance.
View Device Vulnerability & Pen TestingFull-knowledge testing with administrator access and source code.
View White Box Penetration TestingWireless access points are often the easiest path into a network. We test corporate Wi-Fi, guest networks, and device-to-device wireless protocols.
