Mastering EU Medical Device Regulation

Day2

8:00 a.m. – 8:30 a.m.

Registration and Continental Breakfast

8:30 a.m. – 10:30 a.m.

Part A – Overview of the Post-market Activities

    • Identification of the Activities
    • Role in the QMS
    • Annex IX Documentation
    • Notified Body Obligations

Part B – Pre-market Activities

  • Clinical Evaluation (Plan and Report)
  • Risk Management (Plan and File)
  • Benefit-Risk Determination
  • Indicators and Thresholds
  • Exercise B1 – Indicator and Threshold Analysis

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Part C – Post-market Surveillance

  • PMS Plan
  • PMS Report
  • Periodic Safety Update Report (PSUR)
  • Linkage to Other Activities
  • Exercise C1 – Developing Elements of the PMS Plan
  • Exercise C2 – Creating and Updating the PSUR

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:15 p.m.

Part D – Post-market Clinical Follow-up (PMCF)

  • PMCF Plan
  • PMCF Evaluation Report
  • Linkage to Other Activities
  • Exercise D1 – Developing Elements of the PMCF Plan
  • Exercise D2 – Preparing the PMCF Evaluation Report

Part E – Summary of Safety and Clinical Performance (SSCP)

  • Application
  • Content
  • Distribution
  • Exercise E1 – Preparing an SSCP

2:15 p.m. – 2:30 p.m.

Break

2:30 p.m. – 4:30 p.m.

Part F – Vigilance & Trend Analysis

  • Field Safety Corrective Action
  • Incident Classification
  • Reporting Serious Incidents
  • Trend Reporting (Non-serious Incidents)
  • Exercise F1 – Classifying Incidents

Part G – Statistically Significant Increase

  • The Concept of Statistical Significance
  • Trend Reporting Plan
  • Calculating a Trend Line
  • Using Excel to Test for Statistical Significance
  • Using an ISO 14971:2007 Risk Matrix
  • Exercise G1 – Developing the Trend Reporting Plan

4:30 p.m.

End of the Workshop

 

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