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



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