Medical Device Safety and Vigilance: Post-Market Surveillance and Incident Reporting

A medical device is never finished when it leaves the factory. In the EU, a serious incident must reach the competent authority within 15 days. In the US, a death, a serious injury or a reportable malfunction must reach the FDA within 30 days. Miss the clock, or the pattern behind it, and you face a warning letter, a recall and patients harmed by a problem you already knew about. One missed report is an inspection finding. This two-hour online training makes your teams fast, accurate and compliant in device safety: watch, report, act.

Across ten hands-on lessons, this certified course covers the whole post-market cycle with ten step-by-step walkthroughs and seven real device cases, from the surveillance plan to global vigilance under ISO 13485 and the IMDRF framework. Its traceable certificate gives you audit-ready proof that you, or your team, are ready to apply the EU MDR, the IVDR and 21 CFR Parts 803 and 806 in practice.

Why teams choose this course

• Built with medical device vigilance and post-market surveillance experts
• Ten step-by-step walkthroughs, from complaint intake to the PSUR
• Real cases: DePuy ASR, Philips Respironics, Medtronic MiniMed, HeartWare HVAD, Essure, Cochlear
• EU, FDA and IMDRF side by side: one surveillance system that satisfies all three
• One-year access per learner and a CPD/CEU certificate your QA can verify online

What you’ll learn

• Build a post-market surveillance system and plan that meets MDR Articles 83 and 84
• Run complaint handling from intake to closure, with reportability built in
• Apply the serious incident test to devices and in vitro diagnostics and decide what to report
• File on time in the EU with the MIR form and Eudamed, and with the FDA under Part 803
• Detect trends and feed safety signals into the risk management file and CAPA
• Plan a field safety corrective action, write the field safety notice and close the recall
• Write a PSUR, PMS report and PMCF evaluation that survive notified body and FDA inspection

Who should enroll

• Quality, vigilance and complaint handling teams
• Regulatory affairs professionals and the PRRC
• Clinical, service and field support staff
• Importers, distributors and authorised representatives

Upon successful completion, each learner receives a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

Curriculum

Lesson: A Brief History of Medical Device Vigilance

Lesson 1: The Post-Market Landscape: Concepts, Actors and Regulations

Lesson 2: Building the Post-Market Surveillance System and Plan

Lesson 3: Complaint Handling from Intake to Closure

Lesson 4: Incidents, Serious Incidents and the Reportability Decision

Lesson 5: Reporting in the EU: Article 87, the MIR Form and Eudamed

Lesson 6: FDA Medical Device Reporting: 21 CFR Part 803 and MAUDE

Lesson 7: Trend Reporting and Signal Detection

Lesson 8: Field Safety Corrective Actions, Field Safety Notices and Recalls

Lesson 9: Periodic Reporting: PSUR, PMS Report and PMCF

Lesson 10: Global Vigilance and the Inspection-Ready Organization

Conclusion

Glossary

Final Assessment