Garrett Schumacher, MS, CISSPCybersecurity labeling connects design intent to real-world device use. It communicates to clinicians, IT administrators, and healthcare delivery organizations how to install, configure, maintain, and retire a device securely.
Garrett Schumacher, MS, CISSPBy identifying and mitigating risks at design time, manufacturers avoid embedding vulnerabilities into their systems and ensure compliance with international regulations and standards.
Garrett Schumacher, MS, CISSPThe Velentium Medical Cryptographic Assurance Levels (VEL-CAL) framework defines a tiered classification system for selecting cryptographic primitives and configurations in medical device systems.
Garrett Schumacher, MS, CISSPCybersecurity isn’t just a test before launch. At Velentium Medical, it’s built into every phase of development and maintenance. Our Total Product Life-Cycle process ensures your device is secure by design and safe in the field, backed by our templates and expertise to help you navigate the full process.
Garrett Schumacher, MS, CISSPSecurity requirements define what must happen. Controls define how. This distinction is critical for safe, secure product development.
Garrett Schumacher, MS, CISSPThe FDA’s electronic submission system, eSTAR, requires structured cybersecurity artifacts for 510(k), de novo, and PMA submissions. Our guide shows how to complete each section, map your docs, and stay compliant with the latest expectations. Use these graphics and resources to navigate a critical process for getting your products to market.
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