Topics
- Flexibility of the QSRs
- Overview and review of the US QSRs for medical devices
- Quality system requirements
- Definitions
- Audits
- Management responsibility
- Design control
- Personnel
- Design history file (DHF) and device master record (DMR)
- Validation, design transfer, and design changes
- 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
- Lessons learned
- Enforcement actions: case studies
Who should Attend
VPs, CEOs, Attorneys, Compliance officers, Regulatory affairs, Clinical affairs, R&D, Quality assurance, Consultants, CROs and Contractors/subcontractors.
