Articles By Eric Larson

  1. Building The AI-Enabled Medical Device QMS For European Compliance 2/6/2026

    Let's take a closer look at how AI-enabled medical devices and their QMS should be compliant with the EU MDR and the EU AI Act while also adhering to applicable ISO standards.

  2. Master CCI Testing: Complimentary Workshop At PTI Europe 2/5/2026
  3. Selecting A Prefillable Syringe System With Confidence 2/5/2026

    Discover an advancement in the prefillable syringe market, uniquely integrating the syringe barrel, plunger, and needle shield/tip cap into a fully harmonized, verified system from a single supplier.

  4. 02.05.26 -- The 5-Layer Fix For AI Failure In Life Sciences Manufacturing 2/5/2026
    02/05/26
  5. Compliance Under Transformation: Life Sciences And AI At The Crossroads 2/4/2026

    Explore how FDA modernization and AI-driven processes are redefining compliance expectations, as well as what devices and teams can do now to align standards and strengthen quality systems.

  6. Regulated And Resilient: Adapting GxP Operations For Modern Compliance 2/4/2026

    Learn how cross-functional collaboration and connected data make validation simpler, as well as practical ways teams can work together to streamline processes and decision-making.

  7. Safeguarding Biologic Integrity Through Enhanced Component Compatibility 2/4/2026

    For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.

  8. Optimizing Syringe Performance For Reliable Drug Delivery 2/4/2026

    Reliable drug delivery requires precision. Maintaining a robust seal throughout a product’s shelf life is essential to preserve sterility and ensure patient safety during self-administration.

  9. Maintaining Sterility Through Precise Component Design And Manufacture 2/4/2026

    Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.

  10. Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1 2/4/2026

    Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.