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.

    The Agile Embedded Podcast

    Learn how to get your device to market faster AND with higher quality. Join Luca Ingianni and Jeff Gable as they discuss how agile methodologies apply to embedded systems development, with a particular focus on safety-critical industries such as medical devices.


    I'm on a mission to help medical device companies successfully develop and release incredible products. My focus is using, teaching, and evangelizing modern software development practices.

    If you aren't satisfied with the way your organization develops software for your medical device, and feel like there must be a better way, you're right.

    Fixed-cadence sprints might be for hardware too
    Agile Design Inputs
    Pandora's box: Small additions in device functionality that drive big development costs
    Software V&V survey is live
    Agile with a Capital A
    Software Verification in the Real World
    Connascence: a metric for code coupling
    TDD enforces good code architecture
    Why test-driven development works
    What is the goal of testing software?
    I'm still figuring this one out
    How I classify software bugs
    How you can learn Test-Driven Development
    Test-Driven Development makes remote work easier
    Verification and Validation are different things
    Actually, the FDA DOES encourage modern SW development practices
    Does the FDA discourage modern software development practices?
    Automated Verification of Med Devices? Impractical!
    Prerequisites for Continuous Integration
    Repeatable build (and development) environments with Vagrant
    Build machines can suck (sometimes)
    The downsides of automated testing
    If you're just testing manually, you're not really testing
    How can we develop quickly AND safely?
    It's all about risk
    FPGA under 62304? It's cheaper!
    Does FPGA code count as software?
    What is IEC 62304 anyway?
    How to make existing software IEC 62304 compliant
    Can you make my software 62304 compliant?
    Why follow standards?
    Regulations, Guidances, and Standards for Medical Device software development
    The Three Components of the Safety-Critical Mindset
    What it takes to develop medical device software
    Now Publishing Daily