When companies implement an enterprise quality management system (EQMS), one of the first places they often start is with a corrective action solution. This makes business sense when the [...]
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In Manufacturing Industries, Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance ManagementPosted
As regulations and standards evolve, one trend is continually sharpening in focus. ISO 13485 for medical device quality management systems is becoming the international standard for streamlining [...]
The number of U.S. Food and Drug Administration (FDA) inspections dropped dramatically in 2020, with the agency postponing most onsite visits to limit COVID-19 risks. The number of FDA warning [...]
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