HFI

1. Consumable

2. QA

3. QC

4. System configuration

5. **validation activities may begin before requirements are completely verified. However, validation activities cannot be completed before requirements are completely verified.**

6. Privacy and Security

7. Intended User Profile

8. Patient

9. Diagnostics

10. System management

11. Common Management

12. Log Management

13. Maintenance

14. Installation and Upgrade