Regulatory & Quality: Medical Device

1. Our quality management system is current with FDA QMSR and ISO 13485 expectations.

2. Management reviews quality data at least quarterly and acts on it.

3. People are trained and qualified for the work they do, with records to prove it.

4. Design controls and the design history file are complete for every marketed product.

5. Risk management is updated whenever designs, suppliers or field data change.

6. CAPAs are closed on time and checked for effectiveness.

7. Each product has a clear regulatory pathway and a current submission plan.

8. We know which changes need a new submission and which do not.

9. Labeling and claims match what was cleared or approved.

10. Processes, equipment and software are validated.

11. Critical suppliers are qualified, monitored and audited on a schedule.

12. We could pass an unannounced FDA inspection this month.

13. Complaints are logged, investigated and trended within required timelines.

14. Medical device reporting decisions are documented and timely.

15. Field data feeds back into design and risk files.