We understand that your mission is healing, not fighting cyber threats. Security challenges shouldn’t delay life-saving innovations or disrupt patient care. You’re not alone in this struggle. We’ve helped healthcare leaders just like you protect what matters most.
Medical Device Cybersecurity Statistics
993
Vulnerabilities found within medical devices
FDA Mandate
All medical devices must demonstrate cybersecurity throughout lifecycle
Who We Serve
Medical Device Manufacturers
From early-stage startups, to established companies, we support the complete spectrum of medical device development with FDA-ready cybersecurity solutions that fit your stage of growth.
Device Integration Partners
Healthcare technology integrators and distributors needing security expertise for complex device ecosystems, interoperability challenges, and multi-vendor security management.
Digital Health Companies
Software-focused medical technology companies developing connected devices, mobile health apps, and telehealth platforms requiring specialized cybersecurity and regulatory expertise.
Your Device Journey, Secured.
Securing Innovation from Design to Deployment
Pre-Market Cybersecurity
From initial concept through FDA submission, we build security into your device’s DNA. Our pre-market security solutions ensure your innovation reaches patients faster with built-in protection that satisfies regulatory requirements and gives you a competitive edge in the marketplace.
Post-Market Cybersecurity
After deployment, we help you maintain security throughout your device’s operational life. Our post-market security solutions provide continuous monitoring, vulnerability management, and update capabilities that protect patients, prevent recalls, and extend your device’s secure lifecycle.
Pre-Market Cybersecurity
We integrate seamlessly at any stage of your device development cycle.
Strategic Cybersecurity Planning
Delivering comprehensive cybersecurity foundations for medical device through risk assessments, FDA compliance gap analysis, and resource planning. We provide an actionable strategy document with clear implementation roadmaps that integrate with your existing processes, ensuring regulatory compliance and patient safety for new device programs, FDA submissions, or cybersecurity program enhancements.
Cybersecurity Framework Development
Creating Secure Product Development Frameworks (SPDF) that integrate security throughout your device lifecycle, from design to retirement. We establish security architectures, risk management methodologies aligned with ISO 14971 and FDA guidance, documentation strategies for regulatory submissions, and role-specific training programs to ensure your team maintains consistent cybersecurity practices and compliance throughout development.
Architecture Security Implementation
Building cybersecurity foundations into your medical device architecture through secure design principles, authentication and authorization frameworks, encryption systems, and access controls. We implement comprehensive network security architectures, secure communication protocols, and supply chain security controls that protect your device from design through deployment, ensuring "defense in depth" and "least privilege" principles are embedded throughout your system.
Cybersecurity Risk Management
Providing systematic cybersecurity risk oversight through threat modeling, vulnerability assessments, and attack surface analysis. We develop targeted risk mitigation strategies, establish continuous monitoring frameworks for ongoing threat detection, and create and maintain Software Bill of Materials (SBOM) to ensure all security risks are identified, assessed, and reduced to acceptable levels throughout your device lifecycle.
Cybersecurity Controls Implementation
Delivering technical security measures including access control systems, audit logging mechanisms, and encryption protocols tailored to your device requirements. We implement secure authentication systems, update/patch management infrastructure, secure boot mechanisms, and code signing infrastructure to ensure your medical device maintains strong security controls that protect against unauthorized access, tampering, and compromise throughout its operational lifecycle.
Cybersecurity Assessments
Technical security validation through penetration testing, vulnerability scanning, and expert code security reviews to identify exploitable weaknesses before malicious actors can find them. We conduct fuzz testing, security control validation, configuration testing, and update mechanism validation to ensure all implemented security measures function as intended and provide secure protection throughout your device's operational lifecycle.
Documentation Validation
Ensuring accuracy and regulatory compliance through technical documentation review, user guide verification, and security procedure validation. We assess training materials, verify compliance against FDA cybersecurity requirements and applicable standards, and validate risk assessment documentation to confirm all security information is complete, accurate, and effectively communicates necessary procedures to stakeholders throughout your organization.
Documentation Preparation
Creating regulatory-ready documentation packages including technical specifications, risk management records, testing results and analysis, and Software Bill of Materials (SBOM) documentation. We develop detailed security architecture documentation, threat modeling analysis, and user security guidance that demonstrates your device's security controls and compliance with FDA requirements, providing complete documentation support for regulatory submissions and lifecycle management.
FDA Submission Support
Providing assistance in organizing and preparing complete FDA cybersecurity submission packages, including strategic guidance for pre-submission meetings and response strategy development for FDA inquiries. We conduct comprehensive documentation gap analysis and regulatory alignment verification to ensure all cybersecurity documentation meets current FDA guidance requirements, providing end-to-end support from submission preparation through successful regulatory approval.
Post-Market Cybersecurity
Protect your medical devices after deployment with comprehensive security management that ensures continuous compliance and patient safety.
Cybersecurity Risk Management
Establishing and integrating security risk management programs tailored to medical devices, ensuring continuous compliance with FDA requirements while protecting patient safety.
Vulnerability Management
Proactively monitoring the medical device to identify, characterize, and mitigate potential security vulnerabilities before they can be exploited.
Software Lifecycle Management
Monitoring third-party components, validating updates, and managing patches to maintain the security and effectiveness of your medical device's software throughout its lifecycle.
Incident Response Support
Proactively preparing for, responding to, and analyzing cybersecurity incidents with tested response plans and expert guidance.
Communication and Reporting Support
Creating policies for vulnerability disclosure, customer notifications, and FDA reporting that ensure transparent communication and regulatory compliance throughout your device's lifecycle.
Continuous Quality Monitoring
Analyzing post-market data, monitoring device performance, and implementing corrective actions to maintain optimal security and safety standards throughout your device’s lifetime.
What You Can Expect
01
Reduce cybersecurity risks and vulnerabilities
03
Protect patient safety and privacy
02
Achieve and maintain regulatory compliance
04
Dedicated medical device security expertise
Why Choose Us?
Healthcare Cybersecurity Experts Who Understand Your Industry
Accelerated Innovation
Security that speeds time-to-market from device design to FDA approval, transforming regulatory requirements from barriers into competitive advantages.
Complete Ecosystem Protection
Unified security across the entire medical device lifecycle, from initial concept through post-market surveillance and eventual device retirement.
FDA Regulatory Expertise
Deep knowledge of FDA cybersecurity guidance, pre-submission processes, and regulatory expectations that ensures your submissions succeed on the first attempt.
Patient-Centered Security
Security solutions designed around patient safety and clinical effectiveness—ensuring your devices deliver healing while maintaining the highest security standards.
The Hidden Cost of Inadequacy
Security isn't optional in today's landscape. It's essential for:
1
FDA Approval.
New cybersecurity requirements mandate security throughout device lifecycle
2
Market Success.
Healthcare providers demand secure devices that protect patient data
3