Medical AI
Healthcare Platform
A medical AI company partnered with Qualysec to independently assess its web application, desktop application, and API while preparing for FDA 510(k) submission. Through comprehensive penetration testing, compliance-focused reporting, and developer-friendly remediation support, the client strengthened its product security and advanced confidently toward regulatory readiness.
Medical AI
Healthcare Platform
Web, Desktop & API
Security Assessment
17 Employees
Healthcare Technology
FDA 510(k)
Submission Readiness
Preparing software for FDA 510(k) submission requires more than automated security scanning. The client needed a security partner capable of identifying complex application risks while producing documentation aligned with regulatory expectations.
Qualysec combined experienced security researchers with AI-assisted methodologies to perform deep application testing capable of uncovering complex logic flaws across multiple platforms.
Assessment reports were structured to support FDA 510(k) documentation, helping the client simplify regulatory preparation with well-organized technical evidence.
From penetration testing and reporting to remediation guidance and validation, the entire engagement was delivered under one roof, providing a seamless security experience.
Every security observation was presented with technical evidence, business impact, and practical remediation guidance, allowing the development team to resolve issues efficiently.
By combining technical expertise, compliance-focused documentation, collaborative remediation support, and independent validation, Qualysec helped the client strengthen its product before FDA 510(k) submission.
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Trusted worldwide
The desktop application loaded dynamic libraries from insecure locations, creating an opportunity for attackers with local access to execute malicious code through manipulated DLL files.
Potential impact: Potential impact: Unauthorized code execution on clinical workstations.
Several API responses returned unnecessary internal identifiers, system metadata, and medical context, providing attackers with valuable information for reconnaissance.
Potential impact: Potential impact: Increased exposure of internal application details.
Authentication mechanisms lacked effective protections against repeated login attempts, increasing the risk of brute-force and credential-stuffing attacks targeting clinical user accounts.
Potential impact: Potential impact: Unauthorized account compromise.
Certain API endpoints accepted serialized objects without sufficient validation, creating opportunities for remote code execution or unauthorized manipulation of application data.
Potential impact: Potential impact: Data tampering and application compromise.
The web application lacked important browser security protections while session handling did not rotate authentication tokens aggressively following privilege changes.
Potential impact: Potential impact: Session hijacking and user impersonation.
If these security weaknesses had remained undiscovered, attackers could have targeted authentication systems, manipulated application behaviour, exposed sensitive healthcare information, and increased regulatory risk ahead of FDA 510(k) submission. Addressing these issues before submission helped reduce potential delays and strengthened confidence in the platform's security.
Qualysec supported the client beyond penetration testing by providing compliance-focused reporting, developer collaboration, structured remediation guidance, and independent validation designed to support FDA 510(k) preparation.
Every security observation was paired with practical remediation guidance, enabling the client's engineering team to implement improvements efficiently without unnecessary complexity.
The final assessment report was organized to align with FDA 510(k) cybersecurity expectations, making technical evidence easier to include within regulatory documentation.
After remediation activities were completed, Qualysec performed structured retesting to verify implemented fixes and confirm the effectiveness of security improvements.
FDA Documentation Supported
Security reporting prepared to assist regulatory submission activities.
Development Team Enabled
Practical remediation guidance accelerated security improvements.
Independent Security Validation
Security controls verified through structured retesting.
FDA Submission Readiness
The platform progressed toward FDA 510(k) preparation with stronger security assurance and supporting documentation.
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Total No. Of Vulnerabilities
Years in Business
Assessment Completed
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