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.
Starting a medtech company? You're about to venture into a world that blends healthcare advances with business savvy. In a recent Velentium Medical Webinar, hosted by Dan Purvis, startup founders were walked through the essentials of creating a budget for medtech startups—a crucial task that directly impacts your company's success.
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.
Building a Budget for your Medical Device Startup
Discover 7 key reimbursement challenges every MedTech Startup must navigate to insure market success. Gain insights and practical strategies from industry experts.
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