Independent Software Consultant · Minneapolis, MN

Medical device software, from bare metal to FDA submission.

I'm Nick Montelibano, founder of Fractal Logic. For over a decade I've architected and shipped safety-critical software for medical devices: embedded firmware, connected systems, and the compliance documentation that gets them through submission.

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  • IEC 62304
  • FDA submissions
  • First-in-human → market
  • FMEA & risk-based design
Nick Montelibano, medical device software consultant
Years in safety-critical medical device software
10+ Years in safety-critical medical device software
FDA device programs delivered (5 IDE-approved, 1 510(k)-cleared)
6 FDA device programs delivered (5 IDE-approved, 1 510(k)-cleared)
Devices shipped and running in the field
1,000s Devices shipped and running in the field
Aligning cross-functional teams, vendors & stakeholders
Technical lead Aligning cross-functional teams, vendors & stakeholders

Daily drivers

Expertise

Deep experience where it counts

Medical device software demands both engineering depth and regulatory fluency. I bring both, so your team isn't translating between them.

System Architecture

Systems designed to scale from prototype to production.

  • Hardware-software interface design
  • Scalable software architecture
  • Requirements-driven development
  • Large-scale system design

Medical Device & Regulatory

Compliance built in from day one, not bolted on at the end.

  • IEC 62304 compliance expertise
  • FDA submission documentation
  • First-in-human trials through market release
  • Risk-based design & FMEA

Embedded Systems

Reliable firmware where resources are scarce and failure isn't an option.

  • Real-time system development
  • Resource-constrained optimization
  • Bare-metal programming
  • RTOS implementation

Modern Development

Startup velocity with medical-grade rigor.

  • CI/CD pipeline implementation
  • Automated testing frameworks
  • Modern toolchain integration
  • Rapid prototyping practices

Process

From concept to clearance

A development process shaped by the V-model and a decade of taking regulated products to market, without giving up modern velocity.

  1. 01

    Discover

    Intended use, requirements, risk classification, and regulatory strategy, all settled before a line of code is written.

  2. 02

    Architect

    System design and hardware-software interfaces, with traceability from every requirement to its test.

  3. 03

    Build

    Disciplined implementation: code review, CI/CD, and automated coverage from the very first commit.

  4. 04

    Verify & Validate

    Automated test frameworks and the V&V evidence your submission depends on, produced as you go, not after.

  5. 05

    Launch & Support

    Submission support, post-market maintenance, and a codebase your team can carry forward without me.

Platforms

One engineer, the whole stack

Connected medical devices don't stop at the firmware. I build across every layer a modern device touches, so nothing gets lost at the boundaries.

Microcontrollers

STM32, ESP32, and nRF52 on bare metal and RTOS

Embedded Linux

Yocto-class embedded builds and desktop Linux

Mobile

iOS & Android companion apps

Windows

.NET desktop applications

Web

React, Astro, Blazor frontends

Cloud

AWS & GCP connected-device backends

Contact

Let's build something that matters

Whether you're taking a device from whiteboard to first-in-human, or need senior firepower to get an existing system through submission. Either way, I'd like to hear about it.

nick@fractallogic.io
Minneapolis, Minnesota (remote-friendly)
linkedin.com/in/nick-montelibano
Download résumé (PDF)