Medical devices — Quality management systems — Requirements for regulatory purposes

This standard specifies quality management system requirements for organizations that design, develop, produce, install and service medical devices.

1. 1.Scope
2. 2.Normative References
3. 3.Terms and Definitions
4. 4.Quality Management System
5. 5.Management Responsibility
6. 6.Resource Management
7. 7.Product Realization
8. 8.Measurement, Analysis and Improvement