ARTICLES BY ADAM ATHERTON
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![iStock-1199597754]( "The Top 10 Most-Cited Issues In FDA FY2020 Medical Device Inspections")
The Top 10 Most-Cited Issues In FDA FY2020 Medical Device Inspections4/26/2021The first article in this series discussed the background and a few high-level observations of the FDA’s summaries of its medical device quality system inspections. This article digs into the details of the FY2020 observations. What were the top 10 most-cited issues, and what are the takeaways you can implement?
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![Chart Going Up]( "Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success")
Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success3/17/2021Each 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.
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 at www.keb-llc.com or info@keb-llc.com.