Guest Columns

  1. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

  2. Who Exactly Owns Quality? 9/15/2026

    We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of a company.

  3. Chile's Easy Market Ends In 2028 9/11/2026

    For years, Chile has been a comparatively easy to enter market for the medtech industry. That era now has an expiration date. High-risk, technically complex products will be the most affected by a new decree.

  4. Engineering Medical Devices To Improve Oral Delivery Of Biopharmaceuticals 9/10/2026

    Two approved GLP-1 pills validated the demand — and exposed the ceiling that only delivery devices can break.

  5. The Career Path Through QA Produces Better Medtech Engineering Leaders 9/9/2026

    Engineers with direct exposure to failure outcomes are more likely to build risk mitigation in from the start, not bolt it on later. When they're tapped for leadership positions, this makes them better leaders.

  6. Spanish Is Not One Regulatory Language 9/4/2026

    Medical device manufacturers with regulatory plans in Latin America often treat translation as a procurement task. But is the translated document usable by the regulator and other key entities in the country in question?

  7. Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide 8/31/2026

    This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.

  8. Implementing And Optimizing Your eQMS 8/25/2026

    This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.

  9. A Much-Improved Approach For Understanding And Managing Safety Risks 8/18/2026

    Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

  10. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

    The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.