All ecosystems
Ecosystem
Post-Market & Safety
What happens after launch: adverse event reporting (MDR/MIR), recalls, FDA warning letters, periodic safety reports, and the post-market surveillance plans MDR requires.
33 terms
Regulatory5
Quality & Risk1
Clinical & Trials4
Software & AI1
Post-Market22
- 5-Day Report
- Annual Report (PMA)
- Customer Notification Letter
- Electronic Medical Device Reporting(eMDR)
- FDA Recall Classifications I, II, III
- Field Action vs Recall
- Field Safety Corrective Action(FSCA)
- Global Unique Device Identification Database(GUDID)
- Health Hazard Evaluation(HHE)
- Manufacturer Incident Report(MIR)
- Medical Device Recall
- Medical Device Reporting (FDA)(MDR)
- Medical Device Vigilance
- Periodic Safety Update Report(PSUR)
- Post-Market Clinical Follow-up(PMCF)
- Post-Market Performance Follow-up(PMPF)
- Post-Market Surveillance(PMS)
- Post-Market Surveillance Plan
- PSUR (IVDR Specific)
- Removal vs Correction (21 CFR 806)
- Section 522 Postmarket Surveillance(Section 522)
- Trend Reporting (MDR/MIR)