01
Security Architecture
Defines the device's cybersecurity structure, trust boundaries, data flows, authentication mechanisms, and system interactions to demonstrate secure-by-design development practices.
FDA Cybersecurity Experts
Full-Service FDA510k Premarket Cybersecurity: SPDF, SBOMs & eSTAR Documentation
We help medical device teams prepare for premarket cybersecurity expectations with practical testing, documentation, and submission support across SPDF, SBOM generation, threat modeling, and remediation.
50+ submissions supported. No rejections.
FDA compliance focusedFixed-fee engagement optionsUnlimited retests support
Free consultation - no obligation
Talk to an FDA Cybersecurity Expert
TRUSTED BY LEADING MEDTECH COMPANIES
Reviewed by Pabitra Kumar Sahoo, Co-Founder & COO
Last reviewed
50+
FDA submissions supported
100%
Success rate
24/7
Expert support
FDA'S 14 Mandatory Cybersecurity Documents
FDA's 14 Mandatory Cybersecurity Documents
Comprehensive documentation to help you meet FDA requirements and secure your device.
02
Threat Modeling Report
Identifies potential attack paths, threat actors, exploit scenarios, and cybersecurity weaknesses that could impact device functionality, safety, or patient data.
03
Software Bill of Materials (SBOM)
Provides a complete inventory of proprietary, open-source, and third-party software components used within the medical device environment.
04
Software Level of Support & End of Support
Defines software maintenance timelines, support commitments, patching responsibilities, and end-of-life management procedures for device software components.
05
Penetration Testing Report
Validates the effectiveness of cybersecurity controls through simulated real-world attack scenarios performed against the medical device environment.
06
Retesting Report
Confirms that vulnerabilities identified during security assessments were successfully remediated and no longer expose exploitable risks.
07
Security Assessment of Unresolved Anomalies
Documents known unresolved cybersecurity vulnerabilities while demonstrating acceptable residual risk and compensating security controls.
08
Cybersecurity Risk Assessment
Evaluates cybersecurity risks affecting confidentiality, integrity, availability, device functionality, and patient safety throughout the product lifecycle.
09
Safety & Security Risk Assessment of Vulnerabilities
Analyzes how cybersecurity vulnerabilities may directly or indirectly impact clinical operations, patient safety, or device performance.
10
Cybersecurity Control
Defines the technical safeguards implemented to secure the device against unauthorized access, exploitation, and operational compromise.
11
Cybersecurity Risk Management Report
Provides consolidated evidence that cybersecurity risks were identified, mitigated, verified, and managed throughout the device development lifecycle.
12
Cybersecurity Labeling
Provides healthcare organizations and end users with security-related guidance necessary for safe device deployment and operation.
13
Cybersecurity Metrics
Measures the effectiveness of cybersecurity activities, monitoring capabilities, remediation timelines, and ongoing security performance.
14
Cybersecurity Risk Management Plan
Defines the organization's overarching cybersecurity governance strategy across product development, deployment, maintenance, and postmarket operations.
FREE CASE STUDIES
Real FDA Cybersecurity Success Stories
Explore real-world FDA cybersecurity submissions that overcame reviewer deficiencies, strengthened documentation, and achieved successful regulatory outcomes.
- $100k cleared after cybersecurity fixes
- PMA reviewer concerns successfully resolved
- De Novo submission accepted first review
- Complete remediation and compliance journey
Testimonials
What Our Clients Say About Us
Read what our clients say about our services. See how Qualysec has helped several businesses to keep their digital assets safe!
“
Qualysec did a great job identifying vulnerabilities in our web and cloud applications and gave us clear steps to fix them. They stuck to deadlines, handled re-tests, and supported well.
Kenny Kim
Product Manager
FAQ
Frequently Asked Questions
Straight answers from the team that will actually do the work.
We cover SPDF readiness, SBOM support, threat modeling, penetration testing, retesting, risk assessment, and the documentation needed to support premarket submissions.
The timeline depends on the device complexity, evidence readiness, and scope. Simple engagements can move quickly, while multi-component medical devices usually require a longer validation and documentation cycle.
We support 510(k), De Novo, PMA, and IDE-related cybersecurity readiness, along with the documentation and remediation work needed around each one.
The engagement can include retesting support after remediation so your team can revalidate fixes and respond to submission feedback with confidence.
Yes. The regulatory context and evidence expectations can differ, so we adapt the testing and documentation approach to the submission path and device risk profile.
We review the findings, identify the security gaps, prioritize remediation, and help rebuild the supporting evidence needed to address the deficiency response.