ISO 13485 Quality Management System-Medical Devices
Systemic Requirements
- Establish a quality system for medical devices
- Document your medical device quality system
Management Requirements
- Support quality
- Focus on customers
- Establish a quality policy
- Perform quality planning
- Control your quality management system
- Carry out management reviews
Resource Requirements
- Provide quality resources
- Provide quality personnel
- Provide quality infrastructure
- Provide quality environment