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Successful Medical Device & IVD Post Market Surveillance and Vigilance Reporting

In-Person Training Course | 8-9 October, 2024
Blackfriars, London, UK

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Day One

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Day One
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Introduction
  • State of the regulatory framework: EU & UK
  • Implementation in time: horizon 2030
  • Using artificial intelligence
    An overview of Post-Market Surveillance (PMS)
    • Understanding the place of PMS in overall compliance
    • What are the legal obligations for PMS?
    • Key concepts e.g. benefit/risk
    • PMS and Risk Management
    • Understanding the role of the Competent Authority and the Notified Body
      Importance of clinical data
      • Post-Market Clinical Follow Up (PMCF)
      • Post-Market Performance Follow Up (PMPF)
      • Clinical Evaluation Report
        Vigilance (management of adverse incidents)
        • How does vigilance fit into PMS
        • What are the legal requirements for vigilance?
        • Reporting of incidents
        • Investigation of incidents
        • Corrective action
        • Practical vigilance case
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