Implementing ISO 13485:2016

Topics

• Regulatory Framework
• Overview of ISO 13485:2016
• Resource Management
• Management Responsibility
• Supplier Management
• Design and Development
• Process Validation
• Production Processes
• Corrective and Preventive Action
• Monitoring and Measuring

Who should Attend

• Management Representatives
• Quality managers
• Quality assurance and quality control
• Quality engineers
• Regulatory affairs professionals
• Regulatory affairs managers
• R&D engineers
• R&D managers
• Operations managers
• Product design and development
• Manufacturing engineers
• Production managers and supervisors
• Complaint system team members
• Risk managers
• CAPA team members