Case Study

Implantable Medical Device

Source: Trialbee AB
Medical data ipad iStock-1182616138

A leading global medical device company received a warning letter from the United States Food and Drug Administration (FDA), citing a failure to comply with post-approval ePRO (electronic patient-reported outcome assessments) requirements related to a cleared implantable medical device. Find out the solutions and outcomes during the eight week period.

To find out more about Trialbee, visit their Clinical Leader page.


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