Curriculum
- 5 Sections
- 22 Lessons
- 1 Day
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- PMS & Vigilance Framework4
- Situational Awareness ā Regulatory Expectations5
- 2.1PMS & Vigilance obligations by device class (IāIII, Class AāD IVDs)
- 2.2Role of Notified Bodies, Competent Authorities, and EUDAMED database
- 2.3Jurisdictional Differences: EU vs. FDA (MDR vs. MDR adverse event reporting)
- 2.4Case Discussion: EUDAMED reporting timelines and company readiness challenges
- 2.5Trend Reporting, Signal Detection, FSCA Triggers, CAPA linkages
- Real-World Case Insights5
- 3.1Case Study: Device recall due to underreported vigilance incidents
- 3.2Example: IVD manufacturer failing to establish PMCF plan ā NB nonconformity
- 3.3Streamlining PMS via real-world evidence and digital tools
- 3.4Integration with ISO 14971 risk management and ISO 13485 QMS
- 3.5State of the Art, Data Triangulation, Real-World Evidence, Patient Registry Data
- PMS & Vigilance Workshop4
- 4.1Exercise 1: Draft a PMS Plan for a mock Class IIb device
- 4.2Exercise 2: Incident reporting simulation ā responding to Competent Authority within regulatory timelines
- 4.3Exercise 3: Root cause & CAPA mapping from vigilance case data
- 4.4Rapid Response Team, Audit Trail, Traceability Matrix, Lifecycle Documentation
- Strategic Wrap-Up & Roadmap4
- 5.1Embedding PMS as a corporate culture, not a compliance checkbox
- 5.2Leveraging AI/digital platforms for signal detection and literature monitoring
- 5.3Forward-looking strategies: EUDAMED, global harmonization, and PMS maturity models
- 5.4Closing activity: Draft a 90-day PMS/Vigilance improvement roadmap for participantsā organizations
Forward-looking strategies: EUDAMED, global harmonization, and PMS maturity models
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