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Medical Device Security Testing That Understands Neuroscience

Comprehensive security assessments designed for the unique architecture of medical devices and brain-computer interfaces. Conducted by experts who understand both neural signal processing and cybersecurity.

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Why Traditional Security Testing Fails for Medical Devices

You need comprehensive security testing before FDA submission. But traditional penetration testing firms approach your BCI like it's a web application.

They run automated scanners designed for IT systems, testing for vulnerabilities that don't exist in medical devices. When you explain your device architecture using terms like "local field potentials" or "spike sorting," you watch their eyes glaze over.

They miss the attack vectors unique to medical devices:

Manipulation of neural signal processing algorithms that could alter decoded intent
Unauthorized access to raw brain data streams containing the most intimate information humans have
Interference with real-time adaptive control systems that could cause device malfunction
Exploitation of wireless telemetry in implantable devices with severe power and size constraints
Attacks targeting the security handoff between manufacturer and healthcare provider
Compromise of firmware update mechanisms for implanted BCIs

The result: Security assessments that miss critical BCI-specific vulnerabilities. Test reports filled with generic findings that don't address real neural interface risks. Wasted time and money on irrelevant testing. False confidence that leaves genuine security gaps unaddressed. FDA reviewers who aren't convinced by superficial security testing.

You don't need checkbox compliance. You need security testing that actually protects patients.

You need experts who understand both neuroscience and cybersecurity.

We Understand Your Challenge

We've seen what happens when generic security firms try to assess BCIs. We understand the pressure of FDA timelines, investor expectations, and the responsibility of building technology that directly interfaces with the human nervous system.

That's why we specialize in medical device and BCI security

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Our Expertise

✓ FDA Cybersecurity Leadership - Leading FDA cybersecurity work for the implantable BCI community
✓ Published BCI Security Research - Peer-reviewed publications on neural interface vulnerabilities

✓ IEEE/IEC Standards Contributions - Helping create the standards others will follow

✓ Deep Neuroscience Understanding - We speak both neural engineering and cybersecurity

✓ FDA Approval Track Record - Companies we've supported achieved approval with zero cybersecurity findings

We test brain-computer interfaces and medical devices, not web applications.

When You Need Security Testing

Multiple Times Throughout Your Device Lifecycle

Security testing isn't a one-time event. It's an ongoing process throughout development and deployment.

Design Phase

18+ months to FDA

What You Need:

Threat modeling
Security architecture review

Why Now:
Design security controls before you build them. Avoid architectural flaws that are expensive to fix later.

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Our Security Testing Services

Comprehensive Testing for Medical Devices and BCIs

We offer a complete range of security assessment services, each adapted for the unique challenges of medical devices and neurotechnology.

Penetration Testing

Comprehensive security testing of your medical device. We actively test all attack surfaces to identify how an adversary could compromise your device.

What We Test:

Firmware & Embedded Systems
Network & Communication Security
Wireless Security
Application Security
Authentication & Authorization
Data Protection
Update Mechanisms

The Nave Security Difference:

✓ Medical Device-Specific Attack Vectors - We test for neural signal manipulation, brain data exposure, and adaptive algorithm poisoning
✓ Medical Device Constraints - We account for power budgets, real-time requirements, biocompatibility, and patient safety
✓ FDA Compliance - Our testing documentation supports FDA cybersecurity requirements
✓ Patient Safety Focus - We assess risks based on potential patient harm, not just data breach likelihood

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Vulnerability Scanning

Automated and manual scanning to identify known vulnerabilities in your device's software components, dependencies, and configurations.

What We Scan:

Software Components
Known Vulnerabilities
Configuration Issues
Network Services
Common Security Weaknesses
Data Protection
Update Mechanisms

The Nave Security Difference:

✓ Medical Device Context - We filter false positives based on your actual architecture. Not everything flagged by automated tools is actually exploitable in your device.
✓ SBOM Integration - We integrate with your Software Bill of Materials for comprehensive dependency tracking
✓ FDA Alignment - Results formatted to support FDA cybersecurity documentation
✓ Prioritization - Vulnerabilities prioritized by actual risk to your device and patients, not generic severity ratings
✓ Remediation Feasibility - Recommendations account for medical device constraints

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Code Security Review

Manual security review of your medical device source code to identify vulnerabilities that automated tools miss, with deep expertise in medical device and BCI-specific code.

What We Review:

Application Code
Embedded Systems Code
Signal Processing Code (BCIs)
Security-Critical Code
Input Validation & Data Handling

The Nave Security Difference:

✓ Neural Algorithm Expertise - We understand signal processing and can identify vulnerabilities in neural decoding code
✓ ML/AI Security - We assess adversarial robustness, model poisoning, and extraction attacks on BCI decoders
✓ Real-Time Systems - We understand safety-critical real-time code and timing attack vectors
✓ Medical Device Standards - We review against IEC 62304 and medical device secure coding practices
✓ Resource Constraints - We account for embedded system constraints

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Fuzz Testing

Automated testing that sends malformed, unexpected, or random data to your medical device to identify crashes, memory leaks, and security vulnerabilities.

What We Fuzz:

Input Interfaces
Communication Protocols
Signal Processing (BCIs)
File Format Parsers

The Nave Security Difference:

✓ Medical Device Focus - We fuzz with awareness of patient safety impact. Crashes aren't just bugs, they could harm patients.
✓ BCI-Specific Fuzzing - We generate adversarial neural signals and edge cases specific to brain-computer interfaces
✓ Real-Time System Testing - We understand how fuzzing impacts real-time performance requirements
✓ Smart Fuzzing - We use grammar-based and mutation-based fuzzing tailored to your protocols
✓ Crash Analysis - We perform root cause analysis on all crashes to determine security impact

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Threat Modeling

Systematic identification and documentation of security threats specific to your medical device's architecture, functionality, and use cases.

Our Process:

Architecture Analysis
Attack Surface Mapping
Threat Identification
Risk Assessment
Control Mapping

The Nave Security Difference:

✓ Medical Device-Specific Threats - We identify attack vectors unique to medical devices that generic frameworks miss
✓ Patient Safety Focus - Threat impact includes patient harm scenarios, not just data breaches
✓ FDA Alignment - Threat models structured for FDA cybersecurity documentation
✓ Neuroscience Understanding - We can model threats to signal processing, decoding algorithms, and neural data

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Security Control Validation Testing

Testing to verify that your implemented security controls actually work as intended and effectively mitigate the threats they're designed to address.

What We Validate:

Authentication Controls
Authorization Controls
Encryption Controls
Logging and Monitoring
Physical Security Controls
Incident Response Controls

The Nave Security Difference:

✓ Medical Device Context - We validate controls against medical device threat models, not generic IT threats
✓ FDA Traceability - We map control validation to FDA security requirements and your threat model
✓ Patient Safety - We test whether controls fail safely (don't harm patients when they activate)
✓ Real-World Scenarios - We test controls under realistic attack scenarios

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Configuration Testing

Assessment of your medical device's security configuration settings to identify insecure defaults, unnecessary features, and misconfigurations that could lead to vulnerabilities.

What We Test:

Operating System Configuration
Network Configuration
Application Configuration
Database Configuration
Cryptographic Configuration
Medical Device-Specific Configuration

The Nave Security Difference:

✓ Medical Device Standards - We assess against medical device security baselines, not just IT standards
✓ FDA Compliance - Configuration testing supports FDA cybersecurity documentation
✓ Clinical Context - We understand which configurations impact clinical functionality vs. pure security
✓ Vendor Coordination - We assess security handoff configurations (manufacturer vs. healthcare provider responsibilities)

Contact Us

01

Discovery & Proposal

Discovery call to understand your device, architecture, and goals. Then, we deliver a customized assessment plan with clear deliverables, timeline, and transparent pricing.

02

Preparation & Kickoff

Contract execution, test environment setup, and kickoff meeting with your team. We finalize scope and rules of engagement to ensure smooth execution.

03

Security Assessment

Our team conducts security testing with real-time communication. Critical vulnerabilities are reported immediately for rapid response.

04

Report & Remediation

Comprehensive report delivery with findings walkthrough. We provide remediation consulting, retesting of fixes, and FDA-ready documentation.

What Happens Without Proper Security Testing

Every undiscovered vulnerabilities puts your organization at risk:

1

FDA Delays & Additional Costs
6-12 month delays from inadequate security documentation. Emergency testing at premium rates. $2-5M in additional burn you didn't plan for.

2

Patient Safety Risks
Undiscovered vulnerabilities in neural signal processing, brain data exposure, or firmware compromise. Post-market recalls and lawsuits.

3

Market Opportunity Lost
Competitors reach market first. Investors lose confidence. Clinical partners hesitate. Your breakthrough technology delayed.

Secure Your Medical Device with BCI Security Experts

Don't settle for generic security testing that misses medical device-specific vulnerabilities. Work with specialists who combine deep medical device knowledge with comprehensive cybersecurity assessment capabilities.

Medical Device Security Testing That Understands Neuroscience

Why Traditional Security Testing Fails for Medical Devices

We Understand Your Challenge

Our Expertise

When You Need Security Testing

Multiple Times Throughout Your Device Lifecycle

18+ months to FDA

12-18 months to FDA

After FDA approval

Our Security Testing Services

Comprehensive Testing for Medical Devices and BCIs

Penetration Testing

Vulnerability Scanning

Code Security Review

Fuzz Testing

Threat Modeling

Security Control Validation Testing

Configuration Testing

What Happens Without Proper Security Testing

Every undiscovered vulnerabilities puts your organization at risk:

FDA Delays & Additional Costs
6-12 month delays from inadequate security documentation. Emergency testing at premium rates. $2-5M in additional burn you didn't plan for.

Patient Safety Risks
Undiscovered vulnerabilities in neural signal processing, brain data exposure, or firmware compromise. Post-market recalls and lawsuits.

Market Opportunity Lost
Competitors reach market first. Investors lose confidence. Clinical partners hesitate. Your breakthrough technology delayed.

Secure Your Medical Device with BCI Security Experts

Don't settle for generic security testing that misses medical device-specific vulnerabilities. Work with specialists who combine deep medical device knowledge with comprehensive cybersecurity assessment capabilities.

Medical Device Security Testing That Understands Neuroscience

Why Traditional Security Testing Fails for Medical Devices

We Understand Your Challenge

Our Expertise

When You Need Security Testing

Multiple Times Throughout Your Device Lifecycle

18+ months to FDA

Our Security Testing Services

Comprehensive Testing for Medical Devices and BCIs

Penetration Testing

What Happens Without Proper Security Testing

Every undiscovered vulnerabilities puts your organization at risk:

FDA Delays & Additional Costs 6-12 month delays from inadequate security documentation. Emergency testing at premium rates. $2-5M in additional burn you didn't plan for.

Patient Safety Risks Undiscovered vulnerabilities in neural signal processing, brain data exposure, or firmware compromise. Post-market recalls and lawsuits.

Market Opportunity Lost Competitors reach market first. Investors lose confidence. Clinical partners hesitate. Your breakthrough technology delayed.

Secure Your Medical Device with BCI Security Experts

Don't settle for generic security testing that misses medical device-specific vulnerabilities. Work with specialists who combine deep medical device knowledge with comprehensive cybersecurity assessment capabilities.

FDA Delays & Additional Costs
6-12 month delays from inadequate security documentation. Emergency testing at premium rates. $2-5M in additional burn you didn't plan for.

Patient Safety Risks
Undiscovered vulnerabilities in neural signal processing, brain data exposure, or firmware compromise. Post-market recalls and lawsuits.

Market Opportunity Lost
Competitors reach market first. Investors lose confidence. Clinical partners hesitate. Your breakthrough technology delayed.