Articles By Eric Larson

  1. Pharma Services Fill, Finish & Drug Delivery CDMO 11/7/2025

    Sterile fill-finish and device assembly capabilities span global sites, offering scalable solutions, analytical testing, and regulatory compliance for combination products and small-batch technical programs.

  2. A/L/P Assembly, Label And Packaging 11/7/2025

    Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.

  3. Optimize Ophthalmic Device Testing For Enhanced Performance, Compliance 11/6/2025

    Strategic, early testing is essential for ophthalmic device safety, performance, and compliance. Implementing parallel testing and robust data generation shortens timelines and strengthens regulatory submissions.

  4. Key Changes To Biocompatibility And Updates To New FDA Draft Guidance 11/6/2025

    Review key changes in the upcoming version of ISO 10993-1, regulatory expectations for specific in vitro and in vivo assays, and the FDA's expectations regarding chemical characterization.

  5. 11.06.25 -- Rapid Prototyping In Medical Devices 11/6/2025
    11/06/25 Med Device Online Newsletter
  6. Mastering Cultural Intelligence In Global Quality And Regulatory Leadership 11/5/2025

    The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage diversity as competitive advantage.

  7. 11.04.25 -- Achieve Peak Performance With PCD Solutions 11/4/2025

    11/04/25 Med Device Online Newsletter

  8. 11.04.25 -- Maximizing ROI: Community Health Workers In Medtech Trials 11/4/2025
    11/04/25 Med Device Online Newsletter
  9. Enabling Simpler, Quieter, And More Precise Wearables Utilizing Disruptive Pump Technology 11/3/2025

    Disc pumps enable quieter, smaller, and more precise wearable medical devices, improving patient comfort, measurement accuracy, and system reliability for innovative healthcare solutions.

  10. A Better Interpretation Of POH In ISO 24971 11/3/2025

    Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.