Medical Device Penetration Testing: How to Pass FDA 510(k) Cybersecurity Expectations.
StealthNet delivers medical device penetration testing for connected devices, companion apps, and backend APIs, with reports mapped to FDA premarket guidance and AAMI TIR57 and delivered in as little as 48 hours. AI pentests start at $1,500 and hybrid (AI + human) pentests start at $5,000. See our full penetration testing services for broader scope.
FDA submissions without penetration test evidence face Refuse to Accept decisions. Most engagements can start within 24 hours.
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Connected Devices Are Under Attack.
FDA rejects your submission
The FDA's 2023 premarket guidance now requires cybersecurity testing evidence. Submissions without penetration test results face Refuse to Accept (RTA) decisions.
Patient safety is at stake
Vulnerabilities in medical devices can directly impact patient health. Proactive testing prevents potentially life-threatening security incidents.
Specialized testing is expensive
Medical device security firms charge $30K to $80K for comprehensive testing. StealthNet delivers AI pentests starting at $1,500 and hybrid pentests from $5,000.
Pentest Reports Built for FDA Submissions, Not Retrofitted for Them.
AI Pentest
$1,500
- 48-hour delivery
- Exploit-validated findings
- Mapped to FDA premarket guidance
Best for: Post-market monitoring, companion app testing, API security
Hybrid (AI + Human) Pentest
Starting at $5,000
Typical engagements range from $5,000 to $15,000 depending on device complexity
- AI attack simulation + senior US-based pentester validation
- 48-hour first report
- Dedicated project manager + private Slack channel
- Submission-ready report + free retest included
Best for: Pre-market submissions, 510(k) renewals, comprehensive device security
Mapped to FDA Cybersecurity Guidance.
Device Security
Testing of device firmware, communication protocols, and physical interfaces
Backend & Cloud
Assessment of cloud APIs, data storage, and device-to-server communications
SBOM Validation
Software composition analysis and known vulnerability identification
Data Integrity
Testing of patient data protection, encryption, and access controls
AI Handles Speed. Humans Validate Everything.
A named, US-based senior tester validates every finding before your report is delivered.
Reports are mapped to FDA premarket guidance and AAMI TIR57, ready for your submission package.
Most clients receive their first report within 48 hours of scoping call completion.
Medical device companies and SaMD teams have used StealthNet to support 510(k) submissions.
FDA Pentesting Questions
Other Compliance Pentests We Cover
HIPAA Penetration Testing
Healthcare apps + ePHI systems
SOC 2 Penetration Testing
Type I & Type II audit-ready
PCI DSS Penetration Testing
Cardholder data environments
ISO 27001 Penetration Testing
ISMS-aligned testing
NIST 800-53 Penetration Testing
Federal control mapping
CMMC Penetration Testing
DoD contractor compliance
FedRAMP Penetration Testing
Government cloud auth
All Compliance Frameworks
Pick your framework
Pentest Services Used in FDA 510(k) Engagements
Every compliance pentest pulls from these test-type services as needed. Scope is sized to your environment, not padded with hours.
Get Your FDA Pentest Scoped in 24 Hours
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