Table of Contents
- Title and Copyright Information
- Preface
- 1 Revision history
- 2 Introduction
- 3 PMDA Device support in Oracle Argus Safety
- 4 Configuration updates in Argus Console
- 5 Setting up reporting destinations
- 6 Setting up reporting rules
- 7 Medical Device Defect Glossary
- 8 Legacy device case reporting
- 9 Handling case copy in PMDA Device reportable cases
- 10 Nullification reporting
- 11 Acknowledgment handling
- 12 Observations during PMDA testing
- 13 Frequently asked questions (FAQs)