ISO 13485 - Medical Devices: Quality Management Systems 2013

Key Topics

• Discussion of key requirements
• Overview of ISO 13485 Quality Management System
• How should internal audits be conducted
• What written procedures and training are required
• Understanding of what auditors expect

Who should Attend

• Medical Device Regulatory Managers/Personnel
• Medical Device Quality Assurance Managers/Personnel
• Internal Auditors
• Medical Device Manufacturing managers, supervisors & personnel
• Medical Device Project Managers
• Senior management executives (CEO, COO, CFO, etc.) of medical device companies