Articles By Eric Larson

  1. Continuous Readiness By Design: The Connected Quality Batch 10/15/2026

    Inspection readiness is now a daily condition, and disconnected systems, not effort, are the obstacle. Following one batch record through six moments shows where connectivity decides audit-readiness and AI stalls.

  2. Beyond Australia: Why Medtech Startups Are Re-Evaluating FIH Trial Destinations 10/15/2026

    The advice handed to medtech companies planning a first-in-human (FIH) study has been: go to Australia. That advice is now overdue for a rewrite. Not because Australia stopped working, but because the math changed.

  3. A Clinical Data Platform For First-In-Human To Post-Market 10/14/2026

    Running a device study with a small team? See how one platform handles data capture, consent, and long-term follow-up from first-in-human to post-market.

  4. High-Quality, ALCOA+ Device Data Under EU MDR And ISO 14155, Without Building A Data Management Team 10/14/2026

    Lean device team? Learn how expert data management and human-reviewed AI help you deliver high-quality clinical evidence for stronger regulatory submissions.

  5. Run Your EU MDR PMCF Program On One Platform 10/14/2026

    Running EU MDR PMCF for years? Now it all fits on one platform: find patients, re-consent remotely, pull charts with AI, and automate follow-up.

  6. The MDR Paradox: What The December 2025 Easing Takes Off Your Desk, And What You Still Have To Collect 10/14/2026

    The EU’s proposed MDR easing cuts a report, not the duty to collect real-world clinical data. Learn what still applies and how to pick the right post-market evidence method.

  7. The PMCF Decision Guide 10/14/2026

    Proposed EU reforms may remove standalone PMCF reporting, yet the duty to proactively collect clinical data remains. Method selection, notified body defense, and data-capture cost determine what comes next.

  8. Accelerating Enrollment For Direct-To-Patient Observational Studies 10/14/2026

    Removing the handoff between patient self-screening and enrollment changes what a fully virtual observational study can achieve, from conversion at peak intent to completion rates among participants.

  9. Getting Ahead Of PFAS Risk In Pharmaceutical Manufacturing 10/14/2026

    Pharma can’t simply eliminate essential PFAS uses. A phased, risk-based strategy can address footprint, exposure, and supply risks amid regulatory uncertainty.

  10. PFAS In Medical Devices: What's New And What To Do 10/14/2026

    Regulators now separate fluoropolymers from other PFAS, but lifecycle risks remain. Readiness starts with knowing which uses, reporting duties, and exposures matter most.