About Lunchbox Software

25+ years of building software that performs under pressure.

From FDA-regulated medical devices to automotive systems, entertainment platforms, industrial manufacturing, and SEC-compliant financial software — we've built software in environments where failure isn't an option and the stakes are always high.

Our Background

Built from the inside out

25+YRS

Industry Experience

510(k)

FDA Submissions

Lunchbox Software was founded by engineers who spent careers inside complex, high-stakes organizations — not consulting from the outside. We've held CTO and VP Engineering roles across medical device companies, health IT platforms, automotive OEMs and suppliers, entertainment technology firms, financial institutions, and industrial manufacturing operations.

That inside experience spans organizations of every scale — from Series A startups to global enterprises including automotive OEMs, major financial institutions, and broadcast networks. We understand the organizational dynamics, the regulatory pressures, and the engineering tradeoffs that only become visible when you're accountable for the outcome.

Our consulting engagements have spanned the full spectrum — from global enterprises like major automotive OEMs, multinational financial institutions, and Fortune 500 corporations, down to early-stage startups, consumer lifestyle platforms, and venture-backed digital businesses finding their footing. The problems are different at each end of that spectrum, but the standard of engineering isn't.

Beyond strategy and architecture, we can assemble and staff complete technology teams — from QA engineers and software developers to IT operations — giving organizations a single point of accountability for building out technical capability from the ground up.

The fractional model lets us bring that depth to organizations that need senior technical leadership without the overhead of a full-time executive hire — whether that's a Series B startup navigating compliance, an enterprise modernizing legacy infrastructure, or a PE firm evaluating a software acquisition.

Core Expertise

Where we operate

Medical Device & Life Sciences

Class II and Class III device software under IEC 62304. Design history files, risk management per ISO 14971, software verification and validation, and FDA submission support.

Entertainment & Media Technology

High-scale broadcast, streaming, and content delivery platforms. Architecture for millions of concurrent users, low-latency media pipelines, and content management at enterprise scale.

Healthcare Enterprise Platforms

HL7/FHIR integration, EHR connectivity (Epic, Cerner, Meditech), clinical data architecture, and enterprise-scale healthcare application design.

Financial Software & SEC Compliance

SEC-compliant financial platforms, audit trail architecture, SOX controls, and enterprise fintech systems built to withstand regulatory scrutiny.

Technical Due Diligence

Pre-acquisition assessments for PE and VC firms — architecture review, code quality analysis, team capability evaluation, and regulatory risk identification across all verticals.

Credentials & Standards

The standards we work to

FDA 21 CFR Part 11Electronic Records & Signatures
IEC 62304Medical Device Software Lifecycle
ISO 14971Risk Management for Medical Devices
HIPAA / HITECHHealth Information Privacy & Security
HL7 / FHIR R4Healthcare Data Interoperability
ISO 13485Medical Device Quality Management
IEC 62443Industrial Cybersecurity
21 CFR Part 820Quality System Regulation

Let's talk about your technical challenges.

Whether you need a fractional CTO, FDA compliance engineering, or a pre-acquisition technical assessment — we're a direct conversation, not a sales process.