QS Labs' customized consultation serves to guide client organizations to meet quality system requirements and standards by providing expert services in following core competencies:

• Design Control Processes and Project Management
• Product and Customer Complaint Handling Processes
• Internal and External (supplier, OEM) Quality Audits
• Manufacturing Transfer Planning and Execution
• Document Management and Change Control Processes (manual and automated)
• Corrective and Preventive Action Processes

Our experience spans across medical device manufacturers, pharmaceutical companies, and healthcare organizations. The systematic, risk-based approach our consultants advocate and implement are in step with most recent regulatory movements, including:

• FDA's Risk-Based Initiative and 21st Centruy cGMP Guidelines
• FDA's Guidance on Process Analystical Technology (PAT)
• FDA's Guidance for Industry Development and Use of Risk Minimzation Action Plans (RiskMAPs)
• ISO 13485:2003 Medical Device Quality Management Systems Requirements
• Global Harmonization Task Force (GHTF)
• Joint Commision on Accreditation of Healthcare Organizations (jCAHO)

For additional information on how QS Labs consultants can take your company beyond compliance, please contact us.