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Medical Device Reporting Articles & Analysis

2 articles found

Keeping Your Business Compliant with FDA’s UDI Regulations

Keeping Your Business Compliant with FDA’s UDI Regulations

The US Food and Drug Administration (FDA) requires that all medical devices are identified with a unique device identifier (UDI), in both human and machine-readable forms. ...

ByGA International Inc.


Why FDA Compliance Needs A Defined CAPA Process.

Why FDA Compliance Needs A Defined CAPA Process.

The medical device industry is worth hundreds of billions of dollars, but companies who take their eye off the ongoing need for quality management could find themselves under an unwelcome federal compliance spotlight. ...

ByEtQ, LLC

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