FDA-compliant PKI-based authentication for medical devices, enabling device provisioning, ensuring secure communication and regulatory compliance without disrupting performance.
3 of the top 5 medical device manufacturers trust Guardian's proven platform to meet FDA's Section 524B requirements. Our comprehensive PKI-based security covers your entire device lifecycle — from development through post-market surveillance.
Built-in security — not bolted on.
Guardian provides a comprehensive device security platform, combining a flexible software library and robust cloud infrastructure. Provision devices with unique cryptographic identities, enabling secure cloud authentication and controlled access.
North-South protection (device-to-cloud security)
Secure communication between devices and cloud platforms over any network. Supports both unidirectional and bidirectional traffic across various transport technologies with minimal performance impact.
East-West protection (local network security)
Encrypted and authenticated communication between device components. Guardian integrates seamlessly with protocols like DDS to enhance local network security without disrupting real-time operations.
Medical device manufacturers face unprecedented business pressures that threaten both market success and patient safety:
Built for medical device business reality:
Guardian eliminates business risk while accelerating market success through five key advantages:
Proven security platform chosen by top manufacturers
Trusted by leading medical device manufacturers to secure mission-critical devices. Guardian provides the enterprise-grade security and regulatory expertise that industry leaders demand for their most important products.
Accelerate market entry by implementing security in 8 weeks vs 18 months in-house
Guardian's pre-built security framework eliminates the need to develop cryptographic infrastructure from scratch. Ready-to-use components and automated provisioning accelerate your security implementation while maintaining clinical development focus.
Win competitive deals with proven security credentials
Enterprise healthcare customers require security certifications and compliance proof. Guardian provides the documentation, audit trails, and third-party validation that close high-value contracts and build long-term customer relationships.
Save ~$11M over 5 years compared to building in-house
Guardian reduces total security costs from ~$22.8M to ~$11.8M over five years while providing superior capabilities. Eliminate hiring specialized cryptographic teams, reduce compliance overhead, and avoid security incident costs.
Protect your business against evolving threats and regulations
Guardian adapts to changing FDA requirements, emerging cyber threats, and new business models without requiring device re-engineering. Your security investment grows with your business and regulatory landscape.
Medical device security implementation faces complex technical obstacles that conventional IT security approaches cannot address:
Built for medical device business reality:
Guardian addresses every major implementation challenge through six proven technical capabilities:
Establish cryptographic identities for every device with robust key management
Ensure only authorized devices can communicate within your ecosystem through FIPS 140-2 and FIPS 140-3 Level 3 compliant key generation and automated device provisioning workflows.
Add enterprise-grade security to existing devices without modifying source code or affecting FDA clearances — critical for protecting installed base investments.
Drop-in cryptographic security that preserves existing FDA clearances through agent installation with minimal system impact and USB-based secure key provisioning for air-gapped devices.
Adapt to any manufacturing environment
Create segmented security zones for diverse medical device ecosystems
Prevent unauthorized attachments with standardized trust frameworks while enabling secure multi-device communication. Essential for complex surgical systems and integrated medical device networks.
Meet Section 524B requirements out-of-the-box:
Lightweight software library that integrates directly into your devices:
Cloud-based certificate authority and device management platform:
Modern medical devices require sophisticated identity management that goes far beyond traditional IT security approaches:
Guardian's comprehensive identity management addresses every challenge through five specialized approaches:
Ensure consistent security across all third-party manufacturers and suppliers
Guardian provides consistent, robust encryption and authentication frameworks that work regardless of manufacturing location or vendor capabilities. Eliminate supply chain security gaps by applying uniform security standards across your entire ecosystem.
Secure different device generations simultaneously without disrupting operations
Manage security across multiple device versions deployed in the field while ensuring FDA compliance for all variants. Guardian handles diverse configurations enabling gradual security upgrades without mass device recalls or clinical disruption.
Provide robust identity management regardless of network access
Secure devices with minimal, intermittent, or no connectivity through comprehensive authentication and communication channels. Guardian ensures secure interactions even in air-gapped environments while meeting FDA cyber device requirements.
Protect all device communication flows with appropriate controls
Secure both North-South (device-to-cloud) and East-West (device-to-device) communications with robust perimeter defenses, mutual authentication, and secure transport layers. Guardian provides internal network controls without compromising real-time performance.
Identify and block unauthorized attachments that compromise device integrity
Guardian can identify and alert you to unauthorized attachments, preventing access and ensuring patient safety. Only approved, authenticated components can connect, protecting against security vulnerabilities and maintaining system integrity.
In 2023, the PATCH Act granted the FDA legal authority to enforce medical device cybersecurity. As of October 2023, the FDA began issuing notices to manufacturers failing to meet new security standards in 510(k) submissions.
Key enforcement areas include:
Cybersecurity integrated from the start of development
Only authorized users and devices can access the system
Enforcing least-privilege access controls for users and devices
.png){kind=spacer}
Protecting sensitive patient data through encryption & controls
.png)
Ensuring data and system functions remain unaltered
Stay compliant:
Check out our latest whitepapers on medical device cybersecurity requirements
Guardian was built with medical device manufacturers in mind:
Perfect for devices with intermittent network access or air-gapped environments
Only authorized users and devices can access the system
Optimized for resource-constrained embedded systems
Scalable security for multi-device ecosystems and integrated platforms
Medcrypt’s Guardian works side-by-side with RTI Connext’s Security Extensions to provide a comprehensive solution. This integrated solution ensures that medical device manufacturers can effectively secure their devices and meet FDA requirements, potentially avoiding the numerous deficiencies that many are currently facing.
"Our device was manufactured by a third party in an offline facility where keys were managed manually. Medcrypt provided a scalable solution to enable offline provisioning and lifecycle key management. Medcrypt's familiarity with medical device manufacturing, engineering and regulatory environments is why we trust them for all our future cybersecurity needs."
— Director of Product Security, Multinational MDM
Medical device manufacturers face a multitude of challenges when it comes to ensuring their devices meet stringent cybersecurity requirements. Some of the key challenges include:
Guardian's flexible architecture adapts to your specific security requirements and development constraints. Whether you're building new devices or securing existing ones, our platform scales from proof-of-concept to enterprise deployment.
Contact our experts to discuss your specific security challenges and see how Guardian can accelerate your path to FDA compliance while protecting your devices and patients.