FDA-Aligned Penetration Testing for Software-based Medical Devices
Cybersecurity is no longer just a technical concern — it’s a prerequisite for market access. The U.S. Food and Drug Administration (FDA) now expects manufacturers of connected and software-based medical technologies to deliver products that are secure by design, resilient to cyber threats, and supported by ongoing vulnerability management.
In today’s threat landscape, cyber incidents can halt hospital operations and compromise patient safety. FDA recognizes this reality — and requires that manufacturers back their claims with real-world, verifiable evidence. Without tangible evidence of cybersecurity controls, FDA submissions can face delays, additional information requests (AI letters), or post-market enforcement risks.
“We don’t stop at compliance — we test for confidence”
At Sekurno, we help you meet and exceed these expectations. Our FDA-aligned penetration testing is built to demonstrate real security through practical, risk-based evidence — empowering you to show that your device is resilient, your systems are trustworthy, and your submission is ready.
FDA Cybersecurity Expectations:
What Needs to Be Proven
Software validation and risk management are key elements of cybersecurity analyses and demonstrating whether a device has a reasonable assurance of safety and effectiveness.
Identification of security risks
Design requirements for how the risks will be controlled
Evidence that the controls function as designed and are effective in their environment of use for ensuring adequate security
The FDA’s Premarket Cybersecurity Guidance outlines several core expectations that align with secure-by-design principles:
Cybersecurity Testing:
Verifying Security Assurance
Verification and Validation (V&V) methods are used to ensure that cybersecurity controls in medical devices meet requirements and specifications and that they fulfill their intended security purpose. V&V are critical components of a quality management system and are particularly essential for demonstrating "reasonable assurance of cybersecurity" as emphasized in FDA's 2025 guidance.
At its core, cybersecurity V&V proves your device is:
Secure by Design – Security is embedded in the architecture, not bolted on
Risk-Aware – Testing depth matches the level of cybersecurity risk
Threat-Driven – Aligned with your device’s threat model and attack surface
Clinically Grounded – Effective in real-world healthcare environments
FDA-Recommended Cybersecurity Testing
What Should Be Verified?
The FDA recommends testing and documenting the functionality of key security mechanisms. This includes:
Authentication
Verifying credentials and access flows
Secure Communications
Validating TLS, VPNs, and channel integrity
Update Integrity
Testing secure software or firmware update delivery
Authorization
Confirming that user roles and privileges are enforced
Security Logging
Capturing access, updates, and critical security events
Error Handling
Ensuring exceptions don’t leak sensitive data
Encryption
Ensuring correct and effective use of cryptographic protocols
Input Validation
Blocking malformed or malicious input
Monitoring & Alerts
Confirming runtime visibility into security-relevant events
To meet FDA expectations for reasonable assurance of cybersecurity, testing must go beyond internal verification. The FDA strongly encourages independent assessments that provide objective, expert-driven validation of security effectiveness. This means engaging qualified third parties to identify and characterize vulnerabilities through structured exploitation — not just theoretical checks.
At Sekurno, we bring that independence and deep technical expertise — helping you turn cybersecurity testing into submission-ready evidence that builds regulator confidence and elevates patient safety.
Post-Market Vulnerability Management
FDA’s cybersecurity expectations don’t stop at submission — they extend across the entire product lifecycle. Manufacturers must have documented processes for identifying, assessing, and remediating vulnerabilities after the device reaches the market.
This includes:
Ongoing monitoring of vulnerability sources (e.g. NVD, CISA, vendor advisories)
Regular analysis of device-specific exposure to newly discovered threats
Periodic cybersecurity testing to revalidate controls and confirm resilience over time
Timely implementation of mitigations or software updates
Transparent communication with users and healthcare providers
At Sekurno, we support post-market resilience by uncovering vulnerabilities before attackers do — and helping you integrate testing insights into your broader cybersecurity risk management and PMS (post-market surveillance) programs. Our goal is not just to secure the premarket submission — but to future-proof your device in a dynamic threat environment.
Sekurno’s FDA-Aligned Penetration Testing Service
What We Test — Tailored for Software-Based Medical Devices
We assess the full digital ecosystem where your software-based medical device lives, identifying exploitable vulnerabilities that could compromise safety, effectiveness, or data integrity.
FDA-Focused, Threat-Driven Testing Methodology
Our penetration testing process is purpose-built to support FDA cybersecurity expectations. We combine real-world threat simulation with structured verification techniques to help you demonstrate that your security controls aren’t just present — they actually work. Every layer of testing is mapped to critical risk areas the FDA wants you to validate in your premarket submission.
Methodologies
True to our commitment, we don't merely reference methodologies like OWASP and PTES — we embody them. After thorough testing, we conclude with a detailed checklist, ensuring transparent and genuine adherence to these recognized standards.
Submission-Ready Reporting That Builds FDA Confidence
Our deliverables are purpose-built to support FDA’s reasonable assurance of cybersecurity — helping you clearly demonstrate that security risks have been addressed, tested, and controlled across your SaMD or connected medical device.
Compliance Testing Solutions Beyond FDA
Our penetration testing services are designed to make your systems truly secure — not just technically compliant. By focusing on real-world threats and infrastructure risks, we help you meet and exceed the expectations of critical frameworks like GDPR, HIPAA, EU MDR/IVDR, ISO/IEC 27001, and SOC 2. Whether you're preparing for regulatory submissions, client due diligence, or certification audits, we ensure your cybersecurity posture delivers lasting protection and regulatory confidence.
HIPAA
FDA
ISO/IEC 27001
SOC 2
What Our Clients Say
Sekurno delivered everything on time, discovered unexpected vulnerabilities, and increased our peace of mind regarding security. Their clear documentation ensured transparency, and they were excellent at project management. The team was independent, efficient, and highly knowledgeable.
Rodrigo Azevedo, Software Developer, Coreway
