Regulatory-ready cybersecurity for medical devices

Typical cybersecurity outputs are often at odds with quality management system and regulatory submission artifacts. Reviewers expect findings contextualized against your other documentation and traceable to hazard analysis and threat model. And quality processes frequently require sound evidence and methodological support to substantiate findings. Unfortunately most off-the-shelf penetration testing reports do not satisfy these.

A cardiac rhythm management device has a fundamentally different risk profile than a glucose monitor. Understanding this clinical context is vital in scoping, performing testing, and creating a report appropriately prioritized for your specific device and its intended use. Otherwise, you may experience excess cost, delay, and risk to your submission.

Regulatory guidance requires test reports to document both the technical findings and the independence and expertise of the testers. Stratigos' experience and expertise drives us to a rigorous standard: each finding documents a set of techniques that produced a specific condition, with methodology and evidence sufficient for an independent party to reproduce it. That discipline makes our reports defensible under any level of scrutiny, including reviewers, legal counsel, and independent experts.

Regulators expect to see a documented remediation and retesting cycle. Our post-remediation testing addendum documents each original finding's status in an updated device version, including what was retested, what was observed, and how the evidence supports closure. The addendum passes the same independent review process as the original report, giving you a clean, regulator-ready record of the test-remediate-test cycle.

Medical device penetration testing demands a specialized toolkit: firmware reverse engineering, wireless protocol fuzzing, hardware interface analysis, and vulnerability chaining in a safety-critical context. Each member of our team has spent years or decades in these specialties and our methodology reflects that focus. When you engage Stratigos, you get a team that does this work every day for manufacturers for whom safety and effectiveness is a top priority.

For most device programs, development and regulatory timelines influence total cost far more than testing fees. A six-month delay that burns $30K per day in overhead and lost sales is a huge financial burden. Cybersecurity testing that's designed for submission success from the start buys down the greatest risk and cost.