Quality Management

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 [...]

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 [...]