Articles By Eric Larson

  1. 08.18.26 -- Improve Biological Evaluation And Device Design 8/18/2026
    08/18/26
  2. 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.

  3. Don't Lose Sight Of Ophthalmic Injectables' Regulatory Complexity 8/17/2026

    Intravitreal injectables face some of the strictest regulatory scrutiny in drug development. Learn what sponsors need to know about EU GMP Annex 1, USP standards, and container closure integrity to stay compliant.

  4. The Right Sized Medical Manufacturer 8/17/2026

    Medbio combines tooling, molding, automation, assembly, packaging, and quality support to help medical manufacturers reduce complexity, manage risk, and move programs efficiently toward production.

  5. Ophthalmic Drug Delivery: Meeting Modern Challenges With A Next Generation Solution 8/17/2026

    Ophthalmic injectable packaging demands early strategic attention. Learn how silicone oil contamination, particulate limits, and dosing accuracy challenges can derail development programs and what it takes to stay compliant.

  6. 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.

  7. 08.16.26 -- Medical Device Licensing Timelines In India To Shorten Under Proposed Amendments 8/16/2026

    08/16/26 Med Device Online Newsletter

  8. 08.13.26 -- Designing Safer, Smarter Medical Devices 8/13/2026

    08/13/26 Med Device Online Newsletter

  9. The Clear Solution: Navigating Contamination Control For Ophthalmic Injectables 8/12/2026

    As the intravitreal therapy market grows and applicable regulations evolve, continued compliance demands technological savvy and rigorous contamination control.

  10. Understanding Ethylene Oxide Residual Behavior 8/12/2026

    EtO sterilization leaves residuals that can delay device release and create compliance risk. Learn what drives absorption and desorption across materials, geometry, and process conditions under ISO 10993-7.