Medical Device Testing & Test Systems Design

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.