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.

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Services

Custom Development
with Full Documentation

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

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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.

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Expert Software Guidance on Demand

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

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Clients

"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
    Mar 18th, 2020
    Does the FDA discourage modern software development practices?
    Mar 2nd, 2020
    How can we develop quickly AND safely?
    Feb 10th, 2020
    How to make existing software IEC 62304 compliant
    Jan 29th, 2020