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Medical Device Cybersecurity Services
Connected medical devices demand more than regulatory compliance. They require security engineered into every layer of the ecosystem. Zymr helps medical device manufacturers, digital health companies, hospitals, and IoMT platform providers build secure, FDA compliant connected products through secure by design engineering, threat modeling, penetration testing, SBOM management, and post market security operations. Combined with our Medical Device Software Development Services, IoMT Solutions, and Cloud Security Services, we help organizations protect connected devices throughout their lifecycle.
As medical devices become more connected, cyber risks continue to grow. Traditional security practices that focus on testing late in the development cycle are no longer enough. Organizations must now protect devices throughout their entire lifecycle while meeting evolving FDA cybersecurity requirements.
Modern medical device security combines secure engineering, continuous vulnerability management, SBOM governance, and post market monitoring into a single lifecycle strategy. Zymr helps medical device manufacturers, hospitals, and digital health companies build secure, compliant connected products by integrating cybersecurity across Medical Device Software Development Services and IoMT Solutions, from design through deployment and ongoing operations.
FDA Section
524B mandatory for cyber devices
60-Day
FDA patch remediation expectation
100%
device lifecycle security coverage
24×7
continuous vulnerability monitoring
The FDA 524B Mandate: What’s Required Now
Medical device cybersecurity is no longer just a product quality initiative. It has become a regulatory requirement. As connected devices exchange clinical data, connect to hospital networks, and receive software updates throughout their lifecycle, regulators now expect manufacturers to demonstrate how security is engineered into the product, not added after development.
This shift is reflected in FDA Section 524B, which introduced mandatory cybersecurity requirements for connected medical devices. Instead of relying on one-time penetration tests or documentation before launch, manufacturers must now establish secure development practices, maintain a Software Bill of Materials (SBOM), monitor vulnerabilities after deployment, and deliver security updates throughout the device's operational life.
A common misconception is that FDA cybersecurity compliance is simply another documentation exercise. In reality, documentation is only one outcome. The FDA expects organizations to prove that cybersecurity has been built into the architecture, software development lifecycle, risk management processes, and post market operations.
Traditional Approach
- Security reviewed near product release
- One-time penetration testing
- Limited visibility into third-party software
- Static compliance documentation
- Security ends after product launch
Modern FDA 524B Approach
- Security engineered from design through retirement
- Continuous vulnerability monitoring and testing
- Living cybersecurity management plan and evidence
- Continuous SBOM management and component tracking
- Ongoing patching, disclosure, and post market surveillance
Why Medical Device Cybersecurity Has Become a Business Imperative
Manufacturers that cannot demonstrate secure development practices, vulnerability management, and post market security processes risk delayed FDA submissions, slower product launches, increased remediation costs, and reduced competitiveness. At the same time, hospitals and health systems are placing greater emphasis on cybersecurity when evaluating new medical devices, making security a key purchasing criterion.
The Forces Driving Adoption
- FDA Section 524B Requirements
Connected medical devices seeking FDA clearance must now demonstrate cybersecurity throughout the product lifecycle, including secure development, SBOM management, vulnerability monitoring, and coordinated security updates.
- Growing Hospital Procurement Standards
Healthcare providers increasingly evaluate device security alongside clinical performance. Manufacturers that can demonstrate strong cybersecurity practices are better positioned during purchasing decisions.
- Increasing Software Supply Chain Risks
Modern medical devices rely on open source libraries, third party components, cloud platforms, and connected services. Continuous SBOM management and vulnerability tracking have become essential for reducing supply chain risk.
- Rise of Connected Healthcare Ecosystems
As devices integrate with EHRs, IoMT platforms, cloud applications, and remote patient monitoring systems, a vulnerability in one component can impact the broader healthcare environment. Organizations must secure the entire connected ecosystem, not just the device itself.
- Lifecycle Security Expectations
Security responsibilities no longer end when a device ships. Manufacturers are expected to monitor emerging threats, respond quickly to vulnerabilities, and deliver security updates throughout the product's operational life.
Medical Device Cybersecurity Needs
FDA 524B Compliance & Cybersecurity Strategy
Secure by Design Architecture & SDLC
Threat Modeling & Penetration Testing
SBOM Engineering & Vulnerability Management
Post Market Security Operations & CVD
Legacy Device & Hospital Ecosystem Security
Premarket Compliance Layer
Bringing a connected medical device to market requires more than functional validation. Manufacturers must demonstrate that cybersecurity has been considered throughout the design, development, and risk management process. Zymr helps engineering teams generate the technical evidence needed for successful regulatory submissions while embedding security into the product lifecycle from the start.
Premarket Submission Documentation
Zymr prepares technical artifacts for 510(k), De Novo, and PMA submissions, ensuring security evidence is complete, consistent, and aligned with current FDA expectations. This work naturally complements our Medical Device Software Development Services.
Security Risk Assessment
Cybersecurity risks must be evaluated alongside patient safety risks. We perform security risk assessments aligned with ISO 14971, helping manufacturers identify potential threats, assess their impact, and implement appropriate design controls before product release.
Cybersecurity Design Controls
Security requirements should be traceable throughout development. Zymr integrates cybersecurity design controls into engineering workflows and quality management processes, helping organizations align with FDA QMSR requirements while reducing compliance gaps.
Architecture Views & Threat Documentation
Regulators expect manufacturers to clearly demonstrate how device security has been engineered. We create architecture diagrams, trust boundaries, data flow models, and threat documentation that provide reviewers with clear visibility into the product's cybersecurity design.
Labeling & Customer Security Documentation
We prepare customer facing security documentation, deployment guidance, maintenance recommendations, and security configuration instructions that help healthcare organizations operate connected devices securely.
Testing & Assurance Layer
Penetration Testing
Vulnerability Assessment & Scanning
Fuzz Testing & Firmware Analysis
Wireless & BLE Security Testing
Red Team Exercises
Security Verification & Validation
SBOM & Component Management Layer
SBOM Generation
We generate comprehensive Software Bills of Materials (SBOMs) using industry standards such as CycloneDX and SPDX, providing complete visibility into software components required for FDA submissions and ongoing security management.
Third Party & Open Source Risk Management
Every external software component introduces potential risk. Zymr evaluates open source libraries and third party dependencies for licensing, security vulnerabilities, and lifecycle support, enabling manufacturers to make informed technology decisions.
Automated Vulnerability Correlation
Security teams need to know immediately when a newly disclosed CVE affects deployed products. We automate SBOM correlation with vulnerability databases to accelerate risk assessment and remediation planning. This capability integrates seamlessly with our Cloud Security Services for continuous monitoring.
Supply Chain Security
We implement software integrity checks, component verification, dependency governance, and secure build pipelines to reduce supply chain risk while improving overall product resilience. These capabilities are further strengthened through our DevOps Services, enabling secure and repeatable software delivery.
Post Market Security Operations Layer
Continuous Vulnerability Monitoring
Coordinated Vulnerability Disclosure (CVD) Program
30 Day Disclosure & 60 Day Patch Workflow
Security Incident Response
Patch Engineering & Deployment
Post Market Surveillance & Reporting
Connected Ecosystem Security Layer
Device Identity & Certificate Management
Every connected device should have a trusted identity. Zymr implements X.509 certificates, PKI infrastructure, and certificate lifecycle management to authenticate devices, prevent impersonation, and establish trusted communication across healthcare environments.
Edge Security
Edge gateways process sensitive clinical data before it reaches the cloud. We secure edge infrastructure through device hardening, secure access controls, encrypted storage, and runtime protection, helping reduce risks at the network edge.
Encrypted Device-to-Cloud Communication
Clinical data must remain protected throughout transmission. Zymr implements TLS, mTLS, certificate-based authentication, and secure API communication to safeguard data exchanged between medical devices, cloud platforms, and enterprise applications.
FHIR & API Security
As connected devices integrate with EHRs and digital health platforms, API security becomes critical. We implement OAuth 2.0, OpenID Connect, mTLS, API gateways, and FHIR security controls to protect healthcare data while enabling secure interoperability.
Hospital Network Segmentation
Medical devices should never have unrestricted access to hospital networks. Zymr designs network segmentation strategies that isolate connected devices, reduce lateral movement, and limit the impact of potential security incidents.
Zero Trust Device Access
Traditional perimeter security is no longer sufficient for connected healthcare environments. We implement Zero Trust principles by continuously verifying users, devices, and workloads before granting access, strengthening security across modern healthcare ecosystems.
AI Threat Detection Layer
ML Anomaly Detection
Network Traffic Analysis
Medical Device Fleet Monitoring
Behavioral Baselining & Alerting
Threat Intelligence Integration
Predictive Threat Risk Scoring
Legacy & Hospital Side Security Layer
Legacy Device Security Assessment
We assess legacy medical devices to identify security gaps, unsupported software, outdated communication protocols, and configuration risks. These assessments help organizations prioritize remediation based on clinical and operational impact.
Compensating Controls for Unpatched Devices
Many legacy devices cannot be patched or upgraded without affecting certification or patient care. Zymr implements compensating controls such as network isolation, virtual patching, access restrictions, and continuous monitoring to reduce risk without modifying the device itself.
MDS2 Support
Hospitals increasingly request Manufacturer Disclosure Statement for Medical Device Security (MDS2) documentation before deployment. We help manufacturers prepare and maintain accurate MDS2 documentation, enabling healthcare providers to evaluate device security and simplify procurement.
Hospital Medical Device Inventory & Risk Management
Zymr helps healthcare organizations build centralized inventories of connected medical devices, classify assets by risk, monitor device health, and prioritize remediation across large clinical environments. This capability aligns closely with our IoMT Solutions.
Network Microsegmentation for Medical Devices
Flat hospital networks increase the risk of lateral movement during a cyberattack. We design microsegmentation strategies that isolate medical devices, restrict unnecessary communication, and contain threats before they impact critical clinical systems.
Legacy Modernization Roadmap
Zymr helps organizations develop phased modernization roadmaps that balance security improvements, regulatory requirements, budget constraints, and clinical continuity. Combined with our Medical Device Software Development Services, this approach enables a smooth transition toward a more secure and connected medical device ecosystem.
Connected Medical Device Cybersecurity Services & Solutions
AI Native Cybersecurity Platform
A cybersecurity SaaS provider needed to detect and respond to sophisticated threats across high-volume cloud environments. Zymr engineered an AI-powered threat detection platform on GCP using machine learning models, real-time analytics, and scalable cloud architecture to identify anomalous behavior with minimal latency. The same engineering principles can be applied to continuously monitor connected medical device fleets and detect emerging threats before they impact clinical operations.
Project Details →
Cybersecurity Manager for Threat Detection
A global cybersecurity company required a platform capable of collecting, correlating, and analyzing security events from thousands of distributed endpoints. Zymr engineered a centralized threat detection solution with automated alerting, policy management, and real-time security analytics, enabling faster incident response and improved operational visibility. These capabilities translate directly to post-market security operations for connected medical devices.
Project Details →
Community Health Network IoMT Platform
A large healthcare network required a secure IoMT platform to connect thousands of medical devices, including patient monitors, wearables, and infusion systems, across a multi-hospital environment. Zymr engineered a scalable platform that securely integrated connected devices, clinical systems, and analytics while enabling real-time monitoring and early sepsis detection. The engagement demonstrates our ability to secure connected medical device ecosystems at enterprise scale.
Project Details →
Why Zymr
We Engineer Security Into the Product, Not Around It
End-to-End Cybersecurity Across the Device Lifecycle
Connected Ecosystem Security
AI-Native Security Engineering
Healthcare Engineering Meets Cybersecurity Expertise
Global Engineering Teams, Enterprise Delivery
Who We Secure Devices For
Medical Device Manufacturers (OEMs)
Developing connected medical devices requires balancing innovation, regulatory compliance, and product security. Zymr helps OEMs engineer secure-by-design devices with FDA 524B readiness, SBOM management, and lifecycle cybersecurity through our Medical Device Software Development Services.
Digital Health & SaMD Companies
Digital health applications rely on secure APIs, cloud infrastructure, and continuous software updates. We help SaMD providers secure applications, protect patient data, and meet evolving cybersecurity and regulatory requirements.
Hospitals & Health Systems
Hospitals manage thousands of connected and legacy medical devices across complex clinical environments. Zymr improves device security through network segmentation, continuous monitoring, and secure IoMT Solutions that minimize operational risk.
Diagnostic & Imaging Companies
Diagnostic platforms process sensitive clinical data while integrating with EHRs and hospital systems. We secure device communications, APIs, and healthcare integrations to protect data across connected workflows.
Remote Patient Monitoring & Wearable Companies
Connected monitoring devices continuously exchange patient data between homes, mobile apps, and cloud platforms. Zymr engineers secure connectivity, encrypted communications, and scalable device security for modern RPM ecosystems.
Implantable & Surgical Device Manufacturers
High-risk medical devices demand security that protects both software integrity and patient safety. We implement secure firmware, authenticated updates, cryptographic controls, and continuous security validation throughout the product lifecycle.
IoMT Platform Providers
IoMT platforms connect thousands of devices, applications, and cloud services. Zymr secures the entire ecosystem through device identity, API protection, AI-driven monitoring, and Cloud Security Services that safeguard connected healthcare environments.
Solutions We Deliver
FDA 524B Premarket Cybersecurity Package
Secure by Design Device Development
Medical Device Penetration Testing & Security Assessment
SBOM & Vulnerability Management
Post Market Security Operations
AI Powered Medical Device Threat Detection
Technology Stack
Secure Development & DevSecOps
Representative Technologies: GitHub Actions, GitLab CI/CD, Jenkins, SonarQube, Snyk, Checkmarx, Veracode
Identity & Cryptography
Representative Technologies: X.509 Certificates, PKI, HSM, TPM, OpenSSL, HashiCorp Vault
Application & API Security
Representative Technologies: OAuth 2.0, OpenID Connect (OIDC), mTLS, API Gateway, SMART on FHIR, FHIR R4/R5
Security Testing & Validation
Representative Technologies: Burp Suite, OWASP ZAP, Nessus, Metasploit, AFL++, Peach Fuzzer
SBOM & Supply Chain Security
Representative Technologies: CycloneDX, SPDX, Dependency-Track, Trivy, Grype, Syft
Cloud & Container Security
Representative Technologies: AWS Security Hub, Amazon GuardDuty, Microsoft Defender for Cloud, Google Security Command Center, Kubernetes, Istio
AI Threat Detection & SIEM
Representative Technologies: Splunk Enterprise Security, Microsoft Sentinel, Elastic Security, TensorFlow, PyTorch, OpenSearch, MITRE ATT&CK
Frequently Asked Questions
What are Connected Medical Device Cybersecurity Services?
Connected Medical Device Cybersecurity Services help manufacturers and healthcare organizations protect connected devices throughout their lifecycle. They include secure-by-design engineering, threat modeling, penetration testing, SBOM management, FDA cybersecurity compliance, and post-market security operations to reduce cyber risk and maintain regulatory readiness.
What are the FDA premarket cybersecurity requirements?
Manufacturers must demonstrate that cybersecurity has been incorporated into the product through secure development practices, risk assessments, threat modeling, SBOM documentation, cybersecurity management plans, and processes for monitoring and addressing future vulnerabilities.
What is an SBOM, and why does the FDA require it?
A Software Bill of Materials (SBOM) is an inventory of the software components used within a medical device. It provides visibility into third-party and open-source dependencies, enabling manufacturers to quickly identify affected components when new vulnerabilities are disclosed
What is Coordinated Vulnerability Disclosure (CVD)?
A Coordinated Vulnerability Disclosure program defines how manufacturers receive, investigate, prioritize, and resolve reported security vulnerabilities. It enables collaboration with researchers, customers, and regulators while reducing risks to deployed medical devices.
Which cybersecurity standards apply to connected medical devices?
Commonly adopted standards include FDA Section 524B, IEC 81001-5-1, AAMI TIR57, IEC 62304, ISO 14971, ISO 13485, NIST CSF, MITRE ATT&CK, CycloneDX, SPDX, ISO/IEC 29147, and IEC 80001, depending on the product and regulatory requirements.
How does Zymr price Connected Medical Device Cybersecurity Services?
Our engagement models are tailored to each organization's needs. We offer project-based assessments, dedicated engineering teams, ongoing post-market security operations, and end-to-end product security engagements based on device complexity, regulatory scope, and business objectives.
What is FDA Section 524B and what is a "cyber device"?
FDA Section 524B establishes cybersecurity requirements for connected medical devices submitted for FDA review. A cyber device is a medical device that contains software, connects to networks or other systems, and requires cybersecurity controls to ensure its safe and secure operation throughout its lifecycle.
What are the FDA post-market cybersecurity requirements?
Manufacturers are expected to continuously monitor deployed devices for vulnerabilities, assess security risks, coordinate responsible disclosure, develop and validate patches, and communicate updates to customers. Cybersecurity is now an ongoing lifecycle responsibility rather than a one-time compliance activity.
What does Secure by Design mean for medical devices?
Secure by Design means cybersecurity is incorporated into product architecture, software development, firmware, cloud infrastructure, and testing from the beginning rather than being added before release. This reduces remediation costs, improves product resilience, and supports regulatory compliance.
How do you secure legacy medical devices that cannot be patched?
Legacy devices can often be protected through compensating controls such as network segmentation, device isolation, access control policies, continuous monitoring, and virtual patching. These measures reduce exposure without requiring hardware replacement.
Does Zymr secure the entire connected healthcare ecosystem?
Yes. Zymr secures devices, firmware, mobile applications, cloud platforms, APIs, EHR integrations, IoMT infrastructure, and hospital networks, enabling end-to-end protection across the connected healthcare ecosystem.
Ready to secure your connected medical devices, by design, by engineering, for the full lifecycle?
Zymr engineers medical device cybersecurity, secure-by-design SDLC, FDA 524B compliance, SBOM, penetration testing, post-market security operations, and AI threat detection, via GCC squads at 40–60% cost advantage.
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