End-User Procedures

1. Creating and Populating New Regulatory Reports

2. Entering and Reviewing Data for 3500A Reports, or

3. Entering and Reviewing Data for MDV Reports

4. Running 3500A and MDV Reports

5. Generating Regulatory Report Numbers and Submitting Reports

6. Transmitting Electronic Medical Device Reporting Immediately

7. Managing Batch Electronic Medical Device Reporting

8. Reopening a Regulatory Report

9. Creating Supplemental or Follow-Up Regulatory Reports