Black Mesa Systems is a leading tech firm specializing in cutting-edge medical device security. With a commitment to delivering top-notch solutions, our teams work diligently to ensure the privacy, integrity, and resilience of medical devices. Our advanced proactive approach to security. With a deep commitment to innovation and a team of experts dedicated to staying one step ahead of cyber threats, we specialize in developing cutting-edge software solutions that fortify the security of medical devices in an increasingly interconnected healthcare ecosystem.
On December 29, 2022, the Consolidated Appropriations Act, 2023 ("Omnibus") was signed into law. Section 3305 of the Omnibus -- "Ensuring Cybersecurity of Medical Devices" -- amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 524B, Ensuring Cybersecurity of Devices (section 3305). The Omnibus states that the amendments to the FD&C Act shall take effect 90 days after the enactment of this Act, on March 29, 2023.
Our software, consulting and research has continued to influence and evolve alongside the ever-changing cybersecurity landscape. We have impacted 100+ medical facilities directly and consulted with a number of OEM medical device vendors on their software business and product roadmaps.