Medical Device Security Testing (IoMT)
Ensuring patient safety through deep-dive cybersecurity audits. We provide specialized VAPT for connected medical devices, conforming to FDA and global regulatory standards.
Patient Safety Driven Security
In the medical sector, a cybersecurity breach isn't just a data risk; it's a direct threat to human life. Connected pacemakers, infusion pumps, and imaging systems are often built on decade-old legacy software that lacks modern defenses.
ARM Innovations leverages specialized IoMT expertise to provide comprehensive security validation. We combine hardware-level debugging with clinical impact analysis to ensure your devices remain trusted, compliant, and safe for patient use.
- FDA Premarket Cybersecurity Documentation
- MDR/IVDR Technical File Gap Analysis
- Safety-Impact Vulnerability Assessments
- Non-Intrusive Clinical Network Audits
Clinical Security Benchmarks
Our methodology bridges the gap between general IT security and specialized medical device safety standards.
FDA & AAMI Standards
Adherence to FDA Premarket Guidance and AAMI TIR57 for medical device risk management.
Safety-First VAPT
Security testing specifically designed to identify flaws without impacting patient safety or device functionality.
NIST SP 800-213
Following NIST guidelines for securing medical IoT (IoMT) devices and their network ecosystems.
Regulatory Traceability
Detailed mapping of security controls to international healthcare regulations (MDR/IVDR).
Audit Lifecycle Phase
Binary & Firmware Audit
Analyzing device firmware for hardcoded keys, insecure boot processes, and logic vulnerabilities.
Radio Protocol Analysis
Auditing Bluetooth Low Energy (BLE), Zigbee, and proprietary medical radio frequencies for interception.
IoMT Gateway Review
Testing the security of medical gateways that bridge clinical devices to hospital networks.
Clinical Scenario Testing
Simulating attacks in a clinical environment to evaluate the impact on patient monitoring and therapy.
Submission Support
Providing the documentation required for regulatory submissions (eSTAR, Technical File).
Clinical Vulnerabilities
Patient Trust Starts with Security
Don't leave clinical cybersecurity to chance. Partner with medical device experts for your regulatory submission and security validation.