Quality system development and remediation, including QMS implementation, documentation, deviation management, CAPA, NCR, SCAR, complaint handling, risk management, supplier qualification, and management review.

Internal audits, supplier audits, clinical site audits, contract manufacturer and testing lab audits.

Pre-inspection readiness support for FDA, EMA, ISO, and MDSAP audits.

Mock inspections for FDA (BIMO, PAI, GMP), ISO 13485, EUMDR, MDSAP.