QualityHub led a comprehensive 14-month quality system rebuild and FDA remediation for a medical device implant manufacturer, including audits, compliance master planning, and inspection coaching,
QualityHub partnered with international pharmaceutical and medical device companies to proactively enhance quality systems, including CAPA overhauls, compliance plans, investigation training, and FDA inspection preparation.
A global cardiovascular health leader faced a corporate FDA warning letter due to multiple recalls and quality failures, prompting a comprehensive, multi-year remediation effort led