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 professional engineering firm specializing in end-to-end support for the design and production of therapeutic and diagnostic active medical devices, intelligent products, and automated test systems for the medical, energy, and manufacturing industries. With customers all over the world, we have experience working with clients of every size and stage, ranging from startups seeking seed funding to established Fortune 100 companies.
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