Medical Device Quality Management Systems 2013

Key Topics

• Flexibility of the QSRs
• Overview and review of the US QSRs for medical devices
• Quality system requirements
• Definitions
• Audits
• Management responsibility
• Design control: design and development planning, design input, design output, design review, design verification, design validation, design transfer, and design changes
• Personnel
• Device master record (DMR)
• Design history file (DHF)
• Purchasing controls
• Quality system procedures
• Process validation
• Inspection, measuring and test equipment
• Complaint files
• Corrective and preventive action (CAPA)
• Quality requirements for premarket approval (PMA) application
• Servicing
• Enforcement actions: case studies

Who should Attend

• Clinical Affairs Managers, Directors and VPs
• Regulatory Affairs Managers, Directors and VPs
• Quality Managers, Directors and VPs
• Quality Managers, Directors and VPs
• Sales and Marketing Managers, Directors, and VPs
• Compliance Managers and Directors
• Site Managers, Directors, and Consultants
• Complaint Handling and Risk Management Managers and Directors
• Compliance Officers and Legal Counsel
• Senior and Executive Management
• Business Development Managers, Directors, and VPs