Articles By Eric Larson

  1. Why Passing Audits No Longer Predicts Scale 10/8/2026

    Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations multiply, readiness depends on whether evidence stays connected.

  2. Why Audit Success No Longer Predicts Clinical-Stage Performance 10/8/2026

    Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between audit readiness and operational readiness opens quietly.

  3. 5 Hidden Risks In Manual Life Science GRC Systems 10/8/2026

    Spreadsheets and siloed quality systems conceal five compounding exposures, from single-person knowledge dependencies to scalability limits, that tend to surface only when an inspector finds them.

  4. 10.08.26 -- What's New In Medical Device Innovation 10/8/2026

    10/08/26 Med Device Online Newsletter

  5. Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions 10/8/2026

    Teams must assess the drug, the device, the manufacturing process, and the environment in which the product is used as an integrated system, not as separate parts. 

  6. At Medbio, Validation Discipline Starts Early 10/6/2026

    Early decisions can help medical OEMs reduce validation risk, improve manufacturability, strengthen process readiness, and avoid costly late-stage changes.

  7. 10.06.26 -- Europe's Reform: Don't Overlook The IVDR 10/6/2026

    10/06/26 Med Device Online Newsletter

  8. 10.04.26 -- Who Exactly Owns Quality? 10/4/2026

    10/04/26 Med Device Online Newsletter

  9. 10.03.26 -- Med Device Online Best Of September 10/3/2026

    10/03/26 Med Device Online Newsletter

  10. 10.01.26 -- New Insights For Medical Device Quality And Design 10/1/2026

    10/01/26 Med Device Online Newsletter