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
QualityHub has extensive experience supporting companies through consent decrees, providing audits, management roles, and strategic collaboration with FDA and legal teams.
QualityHub specializes in staff augmentation, successfully providing experienced interim and acting quality management professionals to clients facing regulatory compliance challenges and staffing shortages.