Ready, Set, Prep for the Four Types of FDA Inspections As a medical device manufacturer, Federal Drug Administration (FDA) inspections...
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ISO 13485 Requirements and Audits: “What’s the Best Way of Doing This?” Align with the Latest Version of ISO 13485...
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What’s New in ISO 14971:2019 and ISO/TR 24971:2020 Author: Silas Minnick, Senior Quality Engineering Consultant What’s in your ISO 14971…
Three years ago, Anne Wilson only had three staff members at QA Consulting Inc., a firm based in Austin, TX….