Medcrypt Guardian is a security platform designed for medical device manufacturers to manage device security throughout the entire lifecycle. The platform combines a software library and cloud infrastructure to provide PKI-based authentication and cryptographic identity management for medical devices. The platform addresses FDA Section 524B requirements and provides device provisioning capabilities with FIPS 140-2 and FIPS 140-3 Level 3 compliant key generation. Guardian supports both North-South protection for device-to-cloud security and East-West protection for local network security between device components. The platform includes capabilities for securing legacy medical devices without modifying source code or affecting existing FDA clearances through agent installation. It offers flexible provisioning options including automatic certificate provisioning for connected devices, manual provisioning for air-gapped environments, and proxy provisioning for devices without direct internet access. Guardian provides trust zone segmentation to create security zones within medical device ecosystems. The platform supports integration with communication protocols like DDS (Data Distribution Service) for real-time operations. It includes automated provisioning workflows and certificate lifecycle management capabilities. The platform is designed to work across various deployment scenarios including manufacturing facilities, hospitals, home care settings, and field service environments with varying connectivity requirements.