S & W Quality Associates LLC

Medical Device Consulting firm.  QSR & ISO 13485 Auditing  Supplier Auditing  Due Diligence Audits  Design Controls  CAPA Implementation  Quality Manual Development  SOP Development  Development of Inspection Documents  Failure Investigations  Risk Management ISO 14971  CMDCAS  21 CFR 1271 Human Cells, Tissue, and Cellular and Tissue-Based Products  Radioactive Seeds for Prostate Cancer  Complaint Investigation  Process Validations  FMEA Development  FDA Investigation Preparedness  FDA 483 & Warning Letter Remediation  Design Reviews  Management Reviews  Quality Management  Microsoft Office Suite  Statistical Software

• Employees 1
• Founded 2007