Articles By Eric Larson

  1. 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?

  2. 09.03.26 -- Is Your Team Ready For AI-Assisted FDA Inspections? 9/3/2026

    09/03/26 Med Device Online Newsletter

  3. AI-Readiness In A Regulated World: A Practical Playbook For Life Sciences 9/2/2026

    Uncover how life science teams build defensible governance, maintain human oversight, and manage regulatory risks when adopting advanced digital tools.

  4. Advancing Biopsy Device Performance Through Precision Overmolding And Assembly 9/2/2026

    Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.

  5. Six Key Challenges When Precision Has To Scale 9/2/2026

    Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.

  6. POC Diagnostics: 4 Considerations For Bridging The Gap From Development To Commercialization 9/2/2026

    Scaling point-of-care diagnostics requires integrating microfluidics, chemistry, and automated assembly early in development. Aligning these pillars reduces risk and speeds time-to-market.

  7. QMSR Is Done. Now What? 9/1/2026

    Align with FDA QMSR requirements by integrating ISO 13485 standards, moving quality management upstream, and tracking process health metrics to ensure continuous regulatory compliance.

  8. What To Expect In The Next Revision Of IEC 62304 9/1/2026

    Prepare for updates to IEC 62304 by learning how revised process rigor levels and expanded health software scopes impact medical device software development and compliance.

  9. 09.01.26 -- Optimize Your eQMS And Strengthen Quality Systems 9/1/2026

    09/01/26 Med Device Online Newsletter

  10. The New Reality Of Particulate Risk: What Drug Manufacturers Need To Know 8/31/2026

    Particulate-related recalls account for 37% of US FDA injectable drug actions, and evolving FDA and EU GMP requirements are raising the compliance bar for manufacturers.