The software problem in medtech: why the old way of doing compliance is broken

Most medtech quality systems were built for hardware: long development cycles, stable configurations, design outputs you can hold in your hand. Software broke every one of those assumptions, and the compliance model never caught up.

In this keynote from the Greenlight Guru Software Enabled Devices Virtual Summit, Etienne Nichols names what most of the industry has been describing as a symptom rather than the disease. Engineers live in GitHub, Jira, and CI pipelines. Compliance lives in a separate eQMS. Quality teams spend most of their working hours translating between the two. The translation tax is the real problem, and it's the one thing teams can actually change.

What you'll take away:

  • Why the parallel-worlds problem persists, and how to articulate it inside your own org
  • What QMSR, PCCP, and modern IEC 62304 reviewers signal about where the FDA is actually going
  • Why this is the most consequential moment in medtech quality, and what teams who get it right will look like

Watch now!