Fractional CTO Services
Your Fractional CTO. FDA-Ready. Day One.
25+ years of enterprise software leadership — across medical devices, automotive, entertainment, manufacturing, healthcare, and SEC-regulated financial platforms. No ramp-up. No full-time overhead. Just the technical leadership your organization needs.
Technology Experience
FDA Compliance
Medical Device Software
Core Capabilities
Technical leadership where it matters most
Fractional CTO
Senior technical leadership on your terms. We integrate with your team to set architecture direction, manage engineering velocity, and own the technical roadmap — without the full-time executive cost.
FDA Compliance Engineering
21 CFR Part 11, IEC 62304, and HIPAA compliance built into the development lifecycle — not bolted on at audit time.
Medical Device Software
Class II and Class III device software development under IEC 62304. Risk management, design history files, and software lifecycle processes that satisfy FDA scrutiny.
Enterprise Architecture
Scalable, maintainable system design for complex healthcare and life sciences environments. HL7/FHIR integration, EHR connectivity, and enterprise data architecture.
Technical Due Diligence
Pre-acquisition and pre-investment technical assessments for PE and VC firms evaluating healthcare software companies. Risk identification, architecture review, and team capability analysis.
Regulatory Standards
"Most consultants learn your domain on your dime. We've been building FDA-regulated software since before most frameworks existed."
— Lunchbox Software
25+ years of cross-industry depth
Not generalist consulting — deep, continuous experience in medical device and healthcare enterprise software from architecture through FDA submission.
FDA-native, not FDA-adjacent
Compliance is built into how we design and build — not a checklist applied after the fact. We've been through 510(k) submissions, PMA processes, and FDA audits.
Fractional model, full commitment
The economics of a consultant with the accountability of a CTO. Embedded in your team, aligned to your outcomes, without the overhead of a full-time executive hire.
Get Started
Ready to de-risk your next build?
Whether you're navigating a 510(k) submission, scaling a healthcare platform, or evaluating a technical acquisition — let's talk.