ARTICLES BY ADAM ATHERTON

  • Chart Going Up
    Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success
    3/17/2021

    Each year, the FDA performs inspections of medical device quality systems for products planned for or already on the U.S. commercial marketplace and publishes summaries of the inspection observations. This article presents background and high-level observations on the inspection data over time, revealing 3 key takeaways.

web_edit3_Atherton_Adam

Adam Atherton

Adam Atherton, PE, RAC, is an independent consultant to medical device and combination product manufacturers. He develops strategies to address technical feasibility, new product development, remediation, regulatory, clinical, manufacturing, and post-market surveillance for Fortune 200 medical device and pharmaceutical companies as well as startup ventures. He manages key aspects of design control, risk management, product architecture, and quality systems. He graduated from Naval Postgraduate School with his MSEE degree and from California State University, Fresno with his BSEE degree. He can be reached a info@keb-llc.com