Why Stratigos
Assuring safe and effective care delivery in cyber devices demands expertise at the intersection of three disciplines: traditional cybersecurity, medical device safety, and regulatory review. Fluency in one is common. Fluency in all three in a single engagement team is what defines Stratigos. That's why manufacturers choose us for their most consequential submissions.
Six attributes that show up in every engagement
We helped write the rules
Our founder, Beau Woods, has been evaluating medical device cybersecurity for over 20 years and served as an Entrepreneur in Residence at the FDA. Beau is one of a handful of cybersecurity professionals to inform medical device regulatory guidance. That perspective shapes our testing methodology, report structure, and ongoing support, calibrated to what engineering, quality, and regulatory teams can use.
Intersectional expertise
Medical device cybersecurity requires fluency across three domains: cybersecurity research, medical device safety, and regulatory process. Our team operates across all three in a single engagement, which means scoping decisions, testing choices, and report language all reflect what each discipline needs. That intersection is where Stratigos was built to work.
A track record you can rely on
We have supported medical device regulatory submissions from Class I through Class III, through 510(k), PMA, De Novo, and IDE pathways, including novel devices and first-to-market submissions where regulatory scrutiny is highest. Across automated insulin delivery, surgical robotics, bioelectronic medicine, and diagnostics, our testing holds up under the level of review your device will face.
Evidence-grade documentation
Our reports are designed to withstand scrutiny from regulatory reviewers, legal counsel, and independent experts. Every finding documents a specific, directly observable condition with evidence sufficient for an independent party to reproduce it. The deliverable is suitable for engineering teams, medical device files, eSTAR packages, and submissions for regulatory review, as appropriate.
We work with you, not around you
We share preliminary results, provide regular updates during testing, and work alongside your team from scoping through submission support. We view this dialog as integral to ensuring device safety and effectiveness, as well as producing better outputs. When reviewers have questions after submission, we're available to join calls and explain methodology directly.
Startup speed
We deliver results your team can act on in days to weeks, not months. For many of our clients, that retesting can begin even as the final report is reaching them. For manufacturers working against a submission deadline, that efficiency saves effort and cost.
Five questions to ask any medical device penetration testing firm
Every medical device program deserves a testing partner with genuine fluency across cybersecurity, device safety, and regulatory process. If you're evaluating firms, these questions help surface what matters most.
- How has your team worked with regulatory agencies directly to understand their intent and expectations?
- Can you show me a sample report format your clients include in a submission package?
- How do you ensure your results reflect real world threats, not just theoretical ones?
- How much of your work is focused specifically on medical device penetration testing?
- How do you capture the conditions and methodology of a finding so that we can assess its risk within a clinical context?
We're happy to answer all of these questions for Stratigos. Ask any firm you're considering to do the same.