Our team brings a technical understanding of embedded design & development processes and tools, right-sizing security mitigations for constrained resources, and artifact production in compliance with regulatory guidance.
Velentium utilizes a Secure Development Lifecycle. We believe the best way to guarantee a secure system is to weave security throughout the entire development process.
In 2016 the FDA released its guidance on “Postmarket Management of Cybersecurity in Medical Devices,” creating a regulatory expectation for device manufacturers to monitor all third-party software components (TPSCs), e.g., libraries, frameworks, operating systems, utilized in your medical device system for disclosed threats. This ongoing monitoring effort continues for the life of the medical device.
This ongoing vigilance burdens device manufacturers with monitoring, investigating, and assessing the impact of these TPSC vulnerabilities upon your medical device system. This effort can be highly disruptive to current development projects.
Therefore, Velentium’s team of highly skilled cybersecurity professionals have stepped up to the challenge of providing this cybersecurity oversight for all of your utilized TPSC items.
We provide quarterly reports on each product’s TPSC vulnerabilities for manufacturer review, thus freeing manufacturers to return to the business of creating medical devices, not focusing on product implementations of the past.
Velentium is a Houston-based professional engineering firm specializing in the end-to-end design, development, manufacturing and post-market support of therapeutic and diagnostic active medical devices. Our core competencies include active implantable medical devices, systems engineering, firmware & software, cybersecurity, mobile & cloud, electrical & mechanical engineering, human factors & usability, automated test systems, and CGMP manufacturing. With customers all over the world, we have experience working with clients in many situations and stages, ranging from startups seeking seed funding to established Fortune 500 companies.
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