Why Validated DevOps is the Path Forward for Regulated Software
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This article originally appeared in DevOps.com on January 30, 2025. Imagine if the life-saving medical devices you rely on — such as pacemakers, insulin pumps, or advanced surgical robots — were developed faster and more efficiently, all while maintaining the highest safety standards. Wouldn’t you trust v.50 of a pacemaker over v.2? That’s the promise of validated DevOps, a groundbreaking approach that combines the speed of modern software development with the rigorous validation required for safety-critical product compliance.
Traditional software development often prioritizes speed, which can conflict with the stringent validation and risk management processes demanded by regulators such as the FDA, leading to delays in delivering life-saving devices. Validated DevOps bridges this gap by enabling software teams to work with the efficiency of unregulated sectors while adhering to strict safety requirements. It’s that behind-the-scenes engine that drives medical breakthroughs, transforms healthcare and sets a new standard for other safety-critical sectors.
Validated DevOps Brings Together CI/CD and Compliance
At its core, validated DevOps brings together continuous integration and continuous delivery (CI/CD) with compliance-by-design principles. This means that every software update, whether a bug fix or a new feature, is automatically tested and documented to meet FDA requirements. Instead of waiting weeks or months for manual validation, medtech companies can move forward in hours or days, accelerating the pace of innovation without compromising safety or quality.
Automated testing tools are typically a part of a CI/CD pipeline, detecting bugs early and preventing costly errors from progressing further down the pipeline. With rapid feedback to developers, organizations can iterate faster with more reliable software releases.
Erez is passionate about improving patient care and health outcomes with software solutions. Over the last decade, Erez worked in industries including computational mathematics, biotech, and energy, helping build monitoring systems for pharmaceutical equipment and AI for medication management. Before Ketryx, Erez worked with Amgen, the world’s largest biotechnology company, as the head of AI/ML for their medical device division and with Wolfram Research, the builders of Mathematica and Wolfram|Alpha. Erez holds a Master of Science in Electrical Engineering and Computer Science and a Master of Business Administration from the Massachusetts Institute of Technology.
