Medical Device Quality Management Systems 2013 is a webinar that covers topics such as:
- 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
Medical Device Quality Management Systems 2013 brings together:
- 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
