The FDA urges medical device makers to prepare now for the new Quality Management System Regulation. Though similar to ISO 13485, compliance requires active effort.
An FDA warning letter highlights deficiencies in a medical device company’s CAPA quality data analysis procedures, emphasizing the critical need for robust, statistically justified trending
A major medical device company faced a recidivist FDA warning letter due to repeated quality system issues and engaged QualityHub for comprehensive audits and remediation
QualityHub has a top-ranked team of experts that can guide your organization through the complexities of regulatory compliance, resolution of product problems and FDA remediation.
CAPA deficiencies are the most frequently cited issues in regulatory inspections, highlighting the critical role of a robust, well-documented CAPA system across all areas of
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 has extensive experience supporting companies through consent decrees, providing audits, management roles, and strategic collaboration with FDA and legal teams.