Take your Medical Device
Prototype to Production

Embedded Software Development, Processes, and Documentation

Hi, I'm Jeff Gable.

I help CEOs, CTOs, and product development leaders at small medical device companies get their prototype device through FDA and into production.

I handle all aspects of embedded software development, from requirements through V&V and regulatory compliance. Whether you have an existing software team or not, I can help you get your device to market.

Get in Touch →


Custom Development
with Full Documentation

I'll deliver bullet-proof, fully-verified software and a complete documentation package ready for your regulatory submission.

IEC 62304 Compliance
with Minimal Overhead

Have a software team, but don't know what you need to do to be compliant with standards and regulations? I can help.

Expert Software Guidance on Demand

Gain clarity and confidence. Get advice on risk analysis, architecture, testing, or anything else software-related.


"Jeff excels at aligning technical solutions with business goals. His work has been critical to putting us on a path to success."

— Kiernan McGuire, former CEO of Flashback Technologies

Prototype Complete? Starting Development?

Start your design-controlled development process off on the right foot and get everyone on the same page with a Concept of Operations Document.

It's quick, easy, and valuable.

This free guide will walk you through creating yours in just a couple of hours.

    Featured Articles

    I regularly publish articles focused on modern software development for medical devices.

    Here are some of my most popular pieces.

    Test-Driven Development makes remote work easier
    Does the FDA discourage modern software development practices?
    How can we develop quickly AND safely?
    How to make existing software IEC 62304 compliant