Über die Veranstaltung

Keywords:
- Scope and history of quality management
- EN13485 structure and requirements
- Risk-based approach
- Development controls
- Data analysis
- Internal audits

Description:
This course introduces the principles and evolution of quality management for medical devices, focusing on the structure and requirements of EN ISO 13485. Participants will explore a risk-based approach to quality, including development controls, data analysis, and continuous improvement processes. The course also covers planning and conducting internal audits to ensure compliance and effectiveness of the quality management system.