Security Software
Purpose-built software solutions designed to strengthen visibility, privacy, integrity, and resilience across connected medical device environments.
Medical device cybersecurity
Security built for the clinical edge.
Black Mesa Systems helps healthcare organizations and medical device manufacturers move from reactive defense to proactive resilience.
200+medical facilities directly impacted
Since 2017dedicated to medical device security
OEMproduct and software roadmap advisory
Connected care demands a different security model.
Clarity across complex clinical environments.
Medical devices sit at the intersection of patient care, operational continuity, and cyber risk. We combine technology, domain expertise, and applied research to help teams see risk earlier and act with confidence.
Strategic Consulting
Focused guidance for healthcare organizations and OEM vendors navigating security priorities, product decisions, and evolving regulatory expectations.
Applied Research
Research grounded in real clinical and product environments, helping security programs evolve alongside the threat and technology landscape.
Proactive security in a reactive system.
As clinical technology becomes more connected, security can no longer begin after an incident. Resilience starts with understanding the environment, anticipating exposure, and making protection part of the device lifecycle.
“Move security closer to the device, the workflow, and the decisions that shape both.”
A higher standard is now part of the landscape.
Cybersecurity is a lifecycle responsibility.
Section 524B of the Federal Food, Drug, and Cosmetic Act established cybersecurity requirements for manufacturers of certain connected medical devices. The provisions took effect March 29, 2023, reinforcing the need for security planning that extends beyond a single product milestone.
Read the enacted legislationBuilt around a singular focus.
Medical device security—before it became a mandate.
Since 2017, Black Mesa Systems has focused on advancing security for connected medical devices. Our software, consulting, and research have evolved with the cybersecurity landscape while staying grounded in the realities of clinical care and product development.
That work has directly impacted more than 200 medical facilities and informed software and product roadmaps for medical device OEMs.
A more resilient clinical environment starts here
Are your medical devices secure?
Let’s talk about your environment, your priorities, and the next practical move.
Connect with Black Mesa Systems