From characterization to verification and validation, to compliance testing, to quality assurance. In manufacturing, we’ve got the expertise to keep your project on the path to success.
We ask better questions sooner, catching oversights before they become costly delays.
We bring our SMEs to the table to help you refine requirements and identify human factors, needs, and risks, in order to produce a test plan and design test systems that go beyond regulatory demand to verify efficient, reliable device performance.
We offer right-sized custom test solutions to fit your needs.
From configurable platforms and modules to flexible contracts, we offer collaborative, total-solution assistance.
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.
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Blog - Thought Leadership & Expertise
Thought and Commentary for the Medical Device Industry
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.
Subscription Service Includes:
Every quarter, Velentium will review the product’s thirdparty software components and documentation delivered for new exposed vulnerabilities using a multitude of resources including, but not limited to, CVE, NVD, H-ISAC’s SIR, ThreatStream, Vulners, media outlets, and the software component manufacturer.
Software Bill of Materials
Review of software projects to create the essential “software bill of materials” for all utilized TPSC items with revision utilized and OEM details.
Product-Specific Vulnerability Assessment
When vulnerabilities are discovered, Velentium can perform an in-depth analysis to assess the impact on the product and its essential clinical performance. Our report also recommends detailed mitigations customized for your product’s unique requirements.
Velentium is a professional engineering firm, specializing in the design and manufacturing of therapeutic and diagnostic active medical devices. We have experience working with all sizes of clients, ranging from startups seeking seed funding to established Fortune 500 companies. We exist to transform your IP into a safe and secure product that will change lives for a better world.