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.
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. Velentium Medical makes it simple with six foundational security requirements that apply to nearly all connected medical device systems, with deeper product-level requirements and a controls inventory templated for use. Select the PDF to learn about these topics and resources.
AcmeStim Systems A Cybersecurity Case Study
The 12 Required Cybersecurity Artifacts for an FDA Submission
Demystifying FDA Cybersecurity Requirements for Medical Devices
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