Medical Device Penetration Testing (MDOT)
Secure connected healthcare devices before they become a liability. Patient safety is the scope.
What Is Medical Device Penetration Testing?
Medical Device Operational Technology (MDOT) penetration testing evaluates the security of connected medical devices — implantables, patient monitors, infusion pumps, diagnostic systems, and clinical workflows. Unlike standard IoT, medical devices carry direct patient safety consequences.
A vulnerability is not just a data breach. It is a treatment disruption, a misdiagnosis, or worse. Our testing methodology is built around this reality — every finding is evaluated for clinical impact, not just CVSS scores.
Scope of a Medical Device Pentest
From embedded firmware to clinical network integration.
Connected Devices
Infusion pumps, ventilators, patient monitors, wearable health devices. Embedded firmware, communication interfaces, safety-critical function manipulation.
Clinical Networks
HL7, FHIR, DICOM communication protocols. Integration with hospital information systems (HIS), electronic health records (EHR), and PACS.
Mobile and Cloud
Companion apps, telehealth platforms, cloud backends. API testing, data exposure, remote code execution paths.
Embedded Firmware
Firmware reverse engineering, binary analysis, secure boot assessment, update mechanism validation.
Hardware Interfaces
UART, JTAG, SPI, SWD debug interfaces. Physical tampering, fault injection, side-channel analysis.
Wireless Protocols
BLE, Wi-Fi, proprietary RF. Replay attacks, eavesdropping, unauthorized device pairing.
Testing Approaches
Two methodologies for different clinical contexts.
Grey Box
Non-intrusive assessment of deployed devices in clinical environments. Network traffic analysis, protocol evaluation, configuration review. Best for devices in active clinical use.
Best for: Deployed medical devices in active clinical environments.
White Box
Full access with engineering documentation. Firmware analysis, source code review, hardware interface testing. Best for premarket submission and compliance validation.
Best for: Premarket submission, compliance validation, R&D testing.
Our Approach
Patient safety drives every decision.
Threat Modeling
Device use cases, clinical workflows, attack surface mapping. STRIDE methodology applied to patient safety scenarios.
Vulnerability Discovery
Firmware analysis, protocol fuzzing, hardware probing, wireless assessment. Aligned with IEC 81001-5-1 security requirements.
Controlled Exploitation
Proof-of-concept demonstrating clinical impact. Tested in lab environments, never against active patient-connected systems.
Regulatory Reporting
Findings mapped to FDA premarket guidance, EU MDR, IEC 62304, and ISO 81001-5-1. Engineering-ready remediation guidance included.
Our Technical Expertise
Where cybersecurity meets patient safety.
FDA Premarket
Aligned with FDA premarket cybersecurity guidance for medical devices. Documentation supports 510(k) submissions and De Novo pathways.
IEC 81001-5-1
Security requirements for health software. Applied throughout the engagement to support TIR57 compliance.
IEC 62304
Medical device software lifecycle standard. Testing supports safety classification and risk management files.
Patient Safety First
Every finding evaluated for clinical impact. Risk rated by potential harm to patients, not just CVSS.
Request a Medical Device Pentest
Tell us about your device or clinical environment. We'll scope a safe, controlled engagement.