CLIA vs. QSR: What You Don’t Know Can Hurt You

Navigant featured in Med Device Online

Many industries suggest or even require the implementation of a quality management system (QMS) to ensure that products are manufactured to a high quality standard. For medical devices, a QMS ensures that products are high quality, perform as intended, and are safe for their intended use. 

Navigant professionals Paula Gray and Sharon Kvistad discuss how the Clinical Laboratory Improvement Amendments (CLIA) responded to this requirement. They provide explanations into the CLIA regulations and ways you can ensure proper adoption.

 

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